Hydro PC

Chlorpheniramine Maleate:

• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Questions? comments?
• Hydro PC (Chlorpheniramine Maleate) reviews

Drug Facts

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product in a child who is

• now taking a prescription monoamine oxidase inhibitor (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if a child has

• a breathing problem such as chronic bronchitis
• glaucoma
• heart disease
• high blood pressure
• thyroid disease
• diabetes mellitus

Ask a doctor before use if a child is taking sedatives or tranquilizers

When using this product

• excitability may occur, especially in children
• may cause drowsiness
• sedatives and tranquilizers may increase drowsiness effect

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• new symptoms occur

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Applesauce Flavor, Citric Acid, FD&C Blue #1, FD&C Yellow #6, Glycerin, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose

Questions? Comments?

Call 1-800-543-9560

Rev. 05/11

E

NEW

FORMULA

NDC 00485-0096-02

Hydro PC (Chlorpheniramine Maleate)

Pediatric Drops

Antihistamine ▪ Nasal Decongestant

Sugar Free ▪ Alcohol Free ▪ Gluten Free

FOR PROFESSIONAL USE ONLY

Each 1 mL for oral administration

contains:

Hydro PC (Chlorpheniramine Maleate) Maleate

2 mg

Phenylephrine HCl

5 mg

APPLESAUCE FLAVOR

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

Manufactured for:

EDWARDS

Pharmaceuticals, Inc.

Ripley, MS 38663

2 fl. oz. (60 mL)

Hydrocodone Tartrate:

• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in specific populations
• Drug abuse and dependence
• Overdosage
• Description
• Clinical pharmacology
• Nonclinical toxicology
• Clinical studies
• How supplied/storage and handling
• Patient counseling information
• Medication guide obredon oral solution (oh-brĕ-don oral solution) (hydrocodone bitartrate and guaifenesin) each 5 ml contains hydrocodone bitartrate, usp, 2.5 mg; and guaifenesin, usp, 200 mg. c-ii
• Hydro PC (Hydrocodone Tartrate) reviews

1 INDICATIONS AND USAGE

Hydro PC (Hydrocodone Tartrate) Oral Solution is indicated for symptomatic relief of cough and to loosen mucus associated with the common cold.

Important Limitations of Use:

Not indicated for pediatric patients under 18 years of age .

Hydro PC (Hydrocodone Tartrate) Oral Solution is a combination product containing an opioid antitussive and expectorant indicated for:

• Symptomatic relief of cough and to loosen mucus associated with the common cold.

Important Limitations of Use:

Not indicated for pediatric patients under 18 years of age. ( 8.4)

2 DOSAGE AND ADMINISTRATION

Adults and adolescents 18 years of age and older: 10 mL every 4 to 6 hours, not to exceed 6 doses in 24 hours. ( 2.1)

Measure Hydro PC (Hydrocodone Tartrate) Oral Solution with an accurate milliliter measuring device. ( 5.10)

2.1 Recommended dosage

Adults and adolescents 18 years of age and older: 10 mL every 4 to 6 hours, not to exceed 6 doses (60 mL) in 24 hours.

Administer Hydro PC (Hydrocodone Tartrate) Oral Solution by the oral route only. Measure Hydro PC (Hydrocodone Tartrate) Oral Solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose .

3 DOSAGE FORMS AND STRENGTHS

Oral Solution:

Each 5 mL contains Hydro PC (Hydrocodone Tartrate) bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg .

Oral Solution: Each 5 mL contains Hydro PC (Hydrocodone Tartrate) bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg.( 3)

4 CONTRAINDICATIONS

Hydro PC (Hydrocodone Tartrate) Oral Solution is contraindicated in:

• Patients with known hypersensitivity to Hydro PC (Hydrocodone Tartrate) bitartrate, guaifenesin, or any of the inactive ingredients of Hydro PC (Hydrocodone Tartrate) Oral Solution.
• Patients receiving MAOI therapy or within 14 days of stopping such therapy .

• Patients with known hypersensitivity to Hydro PC (Hydrocodone Tartrate) bitartrate, guaifenesin, or any of the inactive ingredients of Hydro PC (Hydrocodone Tartrate) Oral Solution. ( 4)
• Patients receiving monoamine oxidase inhibitor (MAOI) therapy or within 14 days of stopping such therapy. ( 4)

5 WARNINGS AND PRECAUTIONS

• Dose-related respiratory depression: Use with caution.
• Drug Dependence: Prescribe with caution that is appropriate to the use of other opioids. ( 5.3)
• Head injury and increased intracranial pressure: Avoid in patients with head injury, intracranial lesions or increased intracranial pressure. ( 5.4)
• Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating machinery. ( 5.5)
• Acute abdominal conditions: Use with caution in patients with acute abdominal conditions. ( 5.6)
• Coexisting conditions: Use with caution in patients with diabetes, thyroid disease, Addison’s disease, prostatic hypertrophy, or urethral stricture, or asthma. ( 5.11)

5.1 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants

Concomitant use of opioids, including Hydro PC (Hydrocodone Tartrate) Oral Solution, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol .

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol.

Advise both patients and caregivers about the risks of respiratory depression and sedation if Hydro PC (Hydrocodone Tartrate) Oral Solution is used with benzodiazepines, alcohol, or other CNS depressants .

5.2 Respiratory Depression

Hydro PC bitartrate, one of the active ingredients in Hydro PC (Hydrocodone Tartrate) Oral Solution, produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Overdose of Hydro PC (Hydrocodone Tartrate) bitartrate in adults has been associated with fatal respiratory depression, and the use of Hydro PC (Hydrocodone Tartrate) bitartrate in children less than 6 years of age has been associated with fatal respiratory depression. Exercise caution when administering Hydro PC (Hydrocodone Tartrate) Oral Solution because of the potential for respiratory depression. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated .

5.3 Drug Dependence

Hydro PC (Hydrocodone Tartrate) can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of Hydro PC (Hydrocodone Tartrate) Oral Solution. Prescribe and administer Hydro PC (Hydrocodone Tartrate) Oral Solution with the same degree of caution appropriate to the use of other opioid drugs .

5.4 Head Injury and Increased Intracranial Pressure

The respiratory depression effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries. The use of Hydro PC Oral Solution should be avoided in these patients.

5.5 Activities Requiring Mental Alertness

Hydro PC (Hydrocodone Tartrate) bitartrate, one of the active ingredients in Hydro PC (Hydrocodone Tartrate) Oral Solution, may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of Hydro PC (Hydrocodone Tartrate) Oral Solution. Concurrent use of Hydro PC (Hydrocodone Tartrate) Oral Solution with alcohol or other central nervous system depressants should be avoided because additional impairment of central nervous system performance may occur.

5.6 Acute Abdominal Conditions

Hydro PC Oral Solution should be used with caution in patients with acute abdominal conditions since the administration of Hydro PC (Hydrocodone Tartrate) may obscure the diagnosis or clinical course of patients with acute abdominal conditions. The concurrent use of other anticholinergics with Hydro PC (Hydrocodone Tartrate) may produce paralytic ileus .

5.7 Co-administration with Anticholinergics

The concurrent use of anticholinergics with Hydro PC (Hydrocodone Tartrate) may produce paralytic ileus. Exercise caution when using Hydro PC (Hydrocodone Tartrate) Oral Solution in patients taking anticholinergic medications .

5.8 Co-administration with MAOIs or Tricyclic Antidepressants

Hydro PC Oral Solution should not be used in patients receiving MAOI therapy or within 14 days of stopping such therapy. The use of MAOIs or tricyclic antidepressants with Hydro PC (Hydrocodone Tartrate) bitartrate may increase the effect of either the antidepressant or Hydro PC (Hydrocodone Tartrate) .

5.9 Persistent Cough

Hydro PC (Hydrocodone Tartrate) Oral Solution should not be used in patients with a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus).

5.10 Dosing

Patients should be advised to measure Hydro PC Oral Solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, which can result in serious adverse reactions . Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose.

5.11 Coexisting Conditions

Hydro PC (Hydrocodone Tartrate) Oral Solution should be used with caution in patients with diabetes, thyroid disease, Addison's disease, prostatic hypertrophy or urethral stricture, and asthma.

5.12 Renal Impairment

Hydro PC Oral Solution should be used with caution in patients with severe renal impairment.

5.13 Hepatic Impairment

Hydro PC (Hydrocodone Tartrate) Oral Solution should be used with caution in patients with severe hepatic impairment .

6 ADVERSE REACTIONS

Use of Hydro PC (Hydrocodone Tartrate) bitartrate is associated with the following:

• Respiratory depression
• Drug dependence
• Increased intracranial pressure
• Decreased mental alertness with impaired mental and/or physical abilities
• Paralytic ileus

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most common adverse reactions experienced by subjects taking a single dose of Hydro PC (Hydrocodone Tartrate) Oral Solution in the clinical setting include the following: Central Nervous System: headache, dizziness, sedation (somnolence); Gastrointestinal System: nausea, diarrhea; Cardiovascular System: decreased blood pressure; Vascular System: hot flush.

The most common adverse reactions of Hydro PC (Hydrocodone Tartrate) Oral Solution include:

Dizziness, headache, sedation, nausea, and decreased blood pressure. ( 6)

To report SUSPECTED ADVERSE REACTIONS, contact ABER Pharmaceuticals, LLC. at tel: 1-855-461-5102; www.obredon.com or FDA at 1-800-FDA-1088; www.fda.gov/medwatch.

7 DRUG INTERACTIONS

No specific interaction studies have been conducted with Hydro PC Oral Solution.

• Opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants (including alcohol): Avoid using with Hydro PC (Hydrocodone Tartrate) Oral Solution; may exhibit additive CNS depression. ( 7.1)
• MAO inhibitors (MAOIs) or tricyclic antidepressants: Do not use. May increase the effect of either the antidepressant or Hydro PC (Hydrocodone Tartrate). ( 7.2)
• Anticholinergic drugs: Use with caution in order to avoid paralytic ileus and excessive anticholinergic effects. ( 7.3)

7.1 Benzodiazepines, Opioids, Antihistamines, Antipsychotics, Anti-anxiety Agents, or Other CNS Depressants (Including Alcohol)

The use of benzodiazepines, opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants concomitantly with Hydro PC (Hydrocodone Tartrate) Oral Solution may cause an additive CNS depressant effect, profound sedation, respiratory depression, coma, and death and should be avoided .

7.2 MAO Inhibitors or Tricyclic Antidepressants

Do not prescribe Hydro PC Oral Solution if the patient is taking a prescription MAOI (i.e., certain drugs used for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping a MAOI drug. The use of MAOIs or tricyclic antidepressants with Hydro PC (Hydrocodone Tartrate) preparations may increase the effect of either the antidepressant or Hydro PC (Hydrocodone Tartrate) .

7.3 Anticholinergic Drugs

Hydro PC (Hydrocodone Tartrate) should be administered cautiously to persons receiving anticholinergic drugs in order to avoid paralytic ileus and excessive anticholinergic effects .

8 USE IN SPECIFIC POPULATIONS

• Renal Impairment: Use with caution in patients with severe renal impairment.
• Hepatic Impairment: Use with caution in patients with severe hepatic impairment. ( 8.7)

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well controlled studies of Hydro PC (Hydrocodone Tartrate) Oral Solution in pregnant women. Reproductive toxicity studies have not been conducted with Hydro PC (Hydrocodone Tartrate) Oral Solution; however, studies are available with an individual active ingredient or related active ingredient. Hydro PC (Hydrocodone Tartrate) was teratogenic in hamsters. Codeine, an opiate related to Hydro PC (Hydrocodone Tartrate), increased resorptions and decreased fetal weight in rats. Because animal reproduction studies are not always predictive of human response, Hydro PC (Hydrocodone Tartrate) Oral Solution should be used during pregnancy only if the benefit justifies the potential risk to the fetus.

Hydro PC (Hydrocodone Tartrate):

Hydro PC (Hydrocodone Tartrate) has been shown to be teratogenic in hamsters when given in a dose approximately 27 times the maximum recommended human daily dose (MRHDD) (on a mg/m ² basis at a single subcutaneous dose of 102 mg/kg on gestation day 8). Reproductive toxicology studies were also conducted with codeine, an opiate related to Hydro PC (Hydrocodone Tartrate). In a study in which pregnant rats were dosed throughout organogenesis, a dose of codeine approximately 40 times the MRHDD of Hydro PC (Hydrocodone Tartrate) (on a mg/m ² basis at an oral dose of 120 mg/kg/day of codeine) increased resorptions and decreased fetal weight; however, these effects occurred in the presence of maternal toxicity. In studies in which rabbits and mice were dosed throughout organogenesis, doses of codeine up to approximately 20 and 100 times, respectively, the MRHDD of Hydro PC (Hydrocodone Tartrate) (on a mg/m ² basis at oral doses of 30 and 600 mg/kg/day, respectively), produced no adverse developmental effects.

Nonteratogenic Effects: Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.

8.2 Labor and Delivery

As with all opioids, administration of Hydro PC Oral Solution to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

8.3 Nursing Mothers

Caution should be exercised when Hydro PC (Hydrocodone Tartrate) Oral Solution is administered to nursing mothers. Hydro PC (Hydrocodone Tartrate) is known to be excreted in human milk. No studies have been performed to determine if guaifenesin is excreted into breastmilk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Hydro PC (Hydrocodone Tartrate) Oral Solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

Safety and effectiveness of Hydro PC Oral Solution in pediatric patients under 18 years of age has not been established. The use of Hydro PC (Hydrocodone Tartrate) in children less than 6 years of age is associated with fatal respiratory depression .

8.5 Geriatric Use

Clinical studies have not been conducted with Hydro PC (Hydrocodone Tartrate) Oral Solution in geriatric populations. Other reported clinical experience with the individual active ingredients of Hydro PC (Hydrocodone Tartrate) Oral Solution has not identified differences in responses between the elderly and patients younger than 65 years of age. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Renal Impairment

Hydro PC Oral Solution should be given with caution in patients with severe impairment of renal function.

8.7 Hepatic Impairment

Hydro PC (Hydrocodone Tartrate) Oral Solution should be given with caution in patients with severe impairment of hepatic function.

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Hydro PC Oral Solution is a Schedule II controlled prescription containing Hydro PC (Hydrocodone Tartrate) bitartrate and should be prescribed and administered with caution.

9.2 Abuse

Hydro PC (Hydrocodone Tartrate) can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of Hydro PC (Hydrocodone Tartrate) Oral Solution, and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs.

Abuse of guaifenesin has been linked to the formation of kidney stones composed of the major metabolite β-(2-methoxyphenoxy) lactic acid.

9.3 Dependence

Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, Hydro PC (Hydrocodone Tartrate) Oral Solution should be prescribed and administered with caution.

Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy.

10 OVERDOSAGE

No human overdosage data are available for Hydro PC (Hydrocodone Tartrate) Oral Solution.

Hydro PC (Hydrocodone Tartrate):

Overdosage with Hydro PC (Hydrocodone Tartrate) is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, dizziness, ringing in the ears, confusion, blurred vision, eye problems, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdose, apnea, circulatory collapse, cardiac arrest and death may occur.

Guaifenesin:

Overdosage with guaifenesin can cause depression of the central nervous system. While present in polypharmacy overdoses, one case of overdose with only significant levels of guaifenesin has been reported. Symptoms included slurred speech, shallow respirations, reduced heart rate with rhythm sinus bradycardia, followed by asystole.

Treatment of overdosage consists of discontinuation of Hydro PC (Hydrocodone Tartrate) Oral Solution together with institution of appropriate therapy. Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to opioids including Hydro PC (Hydrocodone Tartrate). Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

11 DESCRIPTION

Hydro PC Oral Solution contains Hydro PC (Hydrocodone Tartrate) bitartrate (a centrally-acting opioid antitussive) and guaifenesin (an expectorant).

Each 5 mL dose of Hydro PC (Hydrocodone Tartrate) Oral Solution contains: Hydro PC (Hydrocodone Tartrate) bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg.

Hydro PC (Hydrocodone Tartrate) Oral Solution also contains: artificial raspberry flavor, citric acid, glycerin, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, and saccharin sodium.

11.1 Hydro PC (Hydrocodone Tartrate) Bitartrate

Hydro PC (Hydrocodone Tartrate) Bitartrate is a centrally-acting opioid antitussive and analgesic. It is affected by light and occurs as fine white crystals or crystalline powder which is derived from the opium alkaloid, thebaine. Its chemical name is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5); and may be represented by the following structural formula:

C ₁₈H ₂₁NO ₃ - C ₄H ₆O ₆ - 2½H ₂O MW= 494.50

HCB Chemical Structure

11.2 Guaifenesin

Guaifenesin is an expectorant and occurs as a white powder. Its chemical name is 3-(2-methoxyphenoxy)-1,2- propanediol, and may be represented by the following structural formula:

C ₁₀H ₁₄O ₄ MW= 198.22

GFN Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Hydro PC is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of Hydro PC (Hydrocodone Tartrate) and other opiates is not known; however, Hydro PC (Hydrocodone Tartrate) is believed to act directly on the cough center. In excessive doses, Hydro PC (Hydrocodone Tartrate) will depress respiration. Hydro PC (Hydrocodone Tartrate) can produce miosis, euphoria, and physical and physiological dependence.

Guaifenesin is an expectorant the action of which promotes or facilitates the removal of secretions from the respiratory tract. The precise mechanism of action of guaifenesin is not known; however, it is thought to act as an expectorant by increasing the volume and reducing the viscosity of secretions in the trachea and bronchi. In turn, this may increase the efficiency of the cough reflex and facilitate removal of the secretions.

12.3 Pharmacokinetics

Systemic exposure (in terms of peak plasma concentrations and area under plasma concentration versus time curve) of Hydro PC (Hydrocodone Tartrate) bitartrate and guaifenesin after single dose administration of 10 mL Hydro PC (Hydrocodone Tartrate) Oral Solution are equivalent to respective reference solutions of 5 mL Hydro PC (Hydrocodone Tartrate) bitartrate (5 mg/5 mL), and 10 mL guaifenesin (200 mg/5 mL).

Hydro PC (Hydrocodone Tartrate): Following a single 10 mL oral dose of Hydro PC (Hydrocodone Tartrate) Oral Solution administered to 36 healthy adults (19-74 years), the geometric mean C _max and AUC _0-inf for Hydro PC (Hydrocodone Tartrate) were 12.6 ng/ml and 80.9 ng·hr/ml, respectively. The median time to maximum concentration for Hydro PC (Hydrocodone Tartrate) was about 1.25 hours. Food has no significant effect on the extent of absorption of Hydro PC (Hydrocodone Tartrate). The mean plasma half-life of Hydro PC (Hydrocodone Tartrate) is approximately 5 hours.

Guaifenesin: Following a single 10 mL oral dose of Hydro PC (Hydrocodone Tartrate) Oral Solution administered to 57 healthy adults (19-74 years), the geometric mean Cmax and AUC0-inf for guaifenesin were 3.7 mcg/ml and 4.2 mcg·hr/ml, respectively. The median time to maximum concentration was about 20 minutes. The effect of food on guaifenesin systemic exposure is not considered to be clinically meaningful. The mean plasma half-life of guaifenesin is approximately 1 hour.

Drug interactions

When guaifenesin and Hydro PC (Hydrocodone Tartrate) were administered in combination, the pharmacokinetics for each component were similar to those observed when each component was administered separately.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and reproductive studies have not been conducted with Hydro PC (Hydrocodone Tartrate) Oral Solution; however, published information is available for the individual active ingredients or related active ingredients.

Hydro PC (Hydrocodone Tartrate):

Carcinogenicity studies were conducted with codeine, an opiate related to Hydro PC (Hydrocodone Tartrate). In 2 year studies in F344/N rats and B6C3F1 mice, codeine showed no evidence of tumorigenicity at dietary doses up to 70 and 400 mg/kg/day, respectively (approximately 23 and 65 times, respectively, the MRHDD of Hydro PC (Hydrocodone Tartrate) on a mg/m ² basis).

Guaifenesin:

Carcinogenicity, genotoxicity, or reproductive toxicology studies have not been conducted with guaifenesin

14 CLINICAL STUDIES

Efficacy studies were not conducted with Hydro PC (Hydrocodone Tartrate) Oral Solution. Efficacy of Hydro PC (Hydrocodone Tartrate) Oral Solution is based on demonstration of bioequivalence to the individual comparator products .

16 HOW SUPPLIED/STORAGE AND HANDLING

Hydro PC (Hydrocodone Tartrate) Oral Solution is supplied as a clear, raspberry flavored liquid containing 2.5 mg Hydro PC (Hydrocodone Tartrate) bitartrate and 200 mg guaifenesin in each 5 mL. It is available in:

White HDPE bottles of 16 fl oz. (473 mL): NDC 69166-523-16 (raspberry flavored)

White HDPE bottles of 4 fl oz. (118 mL): NDC 69166-523-04 (raspberry flavored)

Store solution at 20° to 25°C (68° to 77°F).

Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.

17 PATIENT COUNSELING INFORMATION

Overdosage

Advise patients not to increase the dose or dosing frequency of Hydro PC (Hydrocodone Tartrate) Oral Solution because serious adverse events such as respiratory depression may occur with overdosage .

Dosing

Advise patients to measure Hydro PC (Hydrocodone Tartrate) Oral Solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is measured. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose .

Interactions with Benzodiazepines and Other Central Nervous System Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if Hydro PC (Hydrocodone Tartrate) Oral Solution is used with benzodiazepines or other CNS depressants, including alcohol.

Because of this risk, patients should avoid concomitant use of Hydro PC (Hydrocodone Tartrate) Oral Solution with benzodiazepines or other CNS depressants, including alcohol .

Activities Requiring Mental Alertness

Advise patients to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as Hydro PC (Hydrocodone Tartrate) Oral Solution may produce marked drowsiness .

Drug Dependence

Caution patients that Hydro PC (Hydrocodone Tartrate) Oral Solution contains Hydro PC (Hydrocodone Tartrate) bitartrate and can produce drug dependence .

For Medical Information

Contact Medical Affairs Department

Phone: 1-855-461-5102

Manufactured for:

Accelis Pharma

East Windsor, NJ 08520

ACELLIS logo

MEDICATION GUIDE

Hydro PC Oral Solution (Oh-brĕ-don Oral Solution)

(hydrocodone bitartrate and guaifenesin) Each 5 mL contains Hydro PC (Hydrocodone Tartrate) bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg. C-II

What is the most important information I should know about Hydro PC (Hydrocodone Tartrate) Oral Solution?

• Taking Hydro PC (Hydrocodone Tartrate) Oral Solution with benzodiazepines, or other central nervous system depressants, including alcohol can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.
• Hydro PC (Hydrocodone Tartrate) Oral Solution can cause you to be drowsy. Do not drive a car or operate machinery until you know how Hydro PC (Hydrocodone Tartrate) Oral Solution affects you. Hydro PC (Hydrocodone Tartrate) Oral Solution can slow your thinking and motor skills, and may affect your vision.
• Women who breastfeed should talk to their healthcare provider before taking Hydro PC (Hydrocodone Tartrate) Oral Solution.
• Call your healthcare provider or get emergency medical help right away if anyone taking Hydro PC (Hydrocodone Tartrate) Oral Solution has any of the symptoms below:
  • increased sleepiness
  • confusion
  • difficulty breathing
  • shallow breathing
  • limpness
  • your baby has difficulty breastfeeding
• Keep Hydro PC (Hydrocodone Tartrate) Oral Solution in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes Hydro PC (Hydrocodone Tartrate) Oral Solution, get emergency medical help right away.
• Hydro PC (Hydrocodone Tartrate) Oral Solution can cause serious side effects, including death.
• Take Hydro PC (Hydrocodone Tartrate) Oral Solution exactly as prescribed by your healthcare provider. If you take the wrong dose of Hydro PC (Hydrocodone Tartrate) Oral Solution, you could overdose and die.
• Hydro PC (Hydrocodone Tartrate) Oral Solution is not for children under 18 years of age.

What is Hydro PC (Hydrocodone Tartrate) Oral Solution?

• Hydro PC (Hydrocodone Tartrate) Oral Solution is a prescription medicine used to treat a cough and to loosen mucus associated with the common cold, in patients 18 years and older. Hydro PC (Hydrocodone Tartrate) Oral Solution contains two medicines, Hydro PC (Hydrocodone Tartrate) and guaifenesin. Hydro PC (Hydrocodone Tartrate) is a narcotic cough suppressant. Guaifenesin is an expectorant.
• Hydro PC (Hydrocodone Tartrate) Oral Solution is a federal controlled substance (C-II) because it contains Hydro PC (Hydrocodone Tartrate) that can be abused or lead to dependence. Keep Hydro PC (Hydrocodone Tartrate) Oral Solution in a safe place to prevent misuse and abuse. Selling or giving away Hydro PC (Hydrocodone Tartrate) Oral Solution may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
• Hydro PC (Hydrocodone Tartrate) Oral Solution is not for children under 18 years of age. It is not known if Hydro PC (Hydrocodone Tartrate) Oral Solution is safe and effective in children.

Who should not take Hydro PC (Hydrocodone Tartrate) Oral Solution?

• Do not take Hydro PC (Hydrocodone Tartrate) Oral Solution if you are allergic to any of the ingredients in Hydro PC (Hydrocodone Tartrate) Oral Solution. See the end of this Medication Guide for a complete list of ingredients. You may have an increased risk of having an allergic reaction to Hydro PC (Hydrocodone Tartrate) Oral Solution if you are allergic to certain other opioid medicines.
• Do not take Hydro PC (Hydrocodone Tartrate) Oral Solution if you take a medicine for depression called a Monoamine Oxidase Inhibitor (MAOI)
  • Do not take an MAOI within 14 days after you stop taking Hydro PC (Hydrocodone Tartrate) Oral Solution.
  • Do not start Hydro PC (Hydrocodone Tartrate) Oral Solution if you stopped taking an MAOI in the last 14 days.

Before you take Hydro PC (Hydrocodone Tartrate) Oral Solution, tell your healthcare provider about all of your medical conditions, including if you:

• • have a drug dependence
  • have lung or breathing problems
  • have had a head injury
  • have pain in your stomach-area (abdomen)
  • have a history of severe or persistent cough
  • have prostate problems
  • have problems with your urinary tract(urethral stricture)
  • plan to have surgery
  • drink alcohol
  • have kidney or liver problems
  • have diabetes
  • have thyroid problems, such as hypothyroidism
  • are pregnant or plan to become pregnant. It is not known if Hydro PC (Hydrocodone Tartrate) Oral Solution will harm your unborn baby. You and your healthcare provider should decide if you should take Hydro PC (Hydrocodone Tartrate) Oral Solution while you are pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if Hydro PC (Hydrocodone Tartrate) Oral Solution passes into your breast milk. You and your healthcare provider should decide if you will take Hydro PC (Hydrocodone Tartrate) Oral Solution or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Hydro PC (Hydrocodone Tartrate) Oral Solution with certain other medicines can cause side effects or affect how well Hydro PC (Hydrocodone Tartrate) Oral Solution or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you:

• take pain medicines such as narcotics
• take cold or allergy medicines that contain antihistamines or cough suppressants
• take medicines for mental illness (anti-psychotics, anti-anxiety)
• drink alcohol
• take medicines for depression, including monoamine oxidase inhibitors (MAOIs) and tricyclics
• The use of MAOIs or tricyclic antidepressants with Hydro PC (Hydrocodone Tartrate) bitartrate may increase the effect of either the antidepressant or Hydro PC (Hydrocodone Tartrate).

How should I take Hydro PC (Hydrocodone Tartrate) Oral Solution?

• Take Hydro PC (Hydrocodone Tartrate) Oral Solution exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much Hydro PC (Hydrocodone Tartrate) Oral Solution to take and when to take it. Do not change your dose without talking to your healthcare provider.
• Administer Hydro PC (Hydrocodone Tartrate) Oral Solution by the oral route only.
• Ask your pharmacist to give you a measuring device to help you measure the correct amount of Hydro PC (Hydrocodone Tartrate) Oral Solution. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
• If you take too much Hydro PC (Hydrocodone Tartrate) Oral Solution, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Hydro PC (Hydrocodone Tartrate) Oral Solution?

• Hydro PC (Hydrocodone Tartrate) Oral Solution can cause you to be drowsy. Do not drive a car or operate machinery while you take Hydro PC (Hydrocodone Tartrate) Oral Solution until you know how it affects you.
• Avoid drinking alcohol while taking Hydro PC (Hydrocodone Tartrate) Oral Solution. Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of Hydro PC (Hydrocodone Tartrate) Oral Solution?

Hydro PC (Hydrocodone Tartrate) Oral Solution may cause serious side effects, including:

• See “What is the most important information I should know about Hydro PC (Hydrocodone Tartrate) Oral Solution?”
• breathing problems (respiratory depression) which can lead to death. Call your healthcare provider or get emergency treatment right away if you are sleeping more than usual, have shallow or slow breathing, or confusion.
• Physical dependence or abuse. Take Hydro PC (Hydrocodone Tartrate) Oral Solution exactly as your healthcare provider tells you to take it. Stopping Hydro PC (Hydrocodone Tartrate) Oral Solution suddenly could cause withdrawal symptoms.
• Bowel problems including constipation or stomach pain.

The most common side effects of Hydro PC (Hydrocodone Tartrate) Oral Solution include:

• Sleepiness
• Confusion
• nausea and vomiting
• difficulty urinating
• trouble breathing

These are not all the possible side effects of Hydro PC (Hydrocodone Tartrate) Oral Solution.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Hydro PC (Hydrocodone Tartrate) Oral Solution?

• Store Hydro PC (Hydrocodone Tartrate) Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C).
• Safely throw away medicine that is out of date or no longer needed.
• Keep Hydro PC (Hydrocodone Tartrate) Oral Solution and all medicines out of the reach of children.

General information about the safe and effective use of Hydro PC (Hydrocodone Tartrate) Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Hydro PC (Hydrocodone Tartrate) Oral Solution for a condition for which it was not prescribed. Do not give Hydro PC (Hydrocodone Tartrate) Oral Solution to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Hydro PC (Hydrocodone Tartrate) Oral Solution that is written for health professionals.

What are the ingredients in Hydro PC (Hydrocodone Tartrate) Oral Solution?

Active ingredients: Hydro PC (Hydrocodone Tartrate) Bitartrate and Guaifenesin

Inactive ingredients: artificial raspberry flavor, citric acid, glycerin, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, and saccharin sodium

Manufactured for:

Accelis Pharma, East Windsor, NJ 08520

For more information, go to www.obredon.com or call 1-855-461-5102.

This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 09/2016

Phenylephrine Hydrochloride:

• Drug facts
• Purpose
• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Questions? comments?
• Product packaging
• Hydro PC (Phenylephrine Hydrochloride) reviews

Drug Facts

Active ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Hydro PC (Phenylephrine Hydrochloride) Hydrochloride 10 mg

Purpose

Antihistamine

Nasal Decongestant

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

• if you are now taking a prescription monoamine oxidase inhibitor (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to enlargement of the prostate gland
• heart disease
• high blood pressure
• thyroid disease
• diabetes
  

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• excitability may occur, especially in children
• may cause drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase the drowsiness effect
• use caution when driving a motor vehicle or operating machinery
  

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by fever
  

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Hydro PC (Phenylephrine Hydrochloride) Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD &C Blue #1 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose.

Questions? Comments?

Call1-800-882-1041

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355 Rev. 02/12

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 50991-782-60

Hydro PC (Phenylephrine Hydrochloride)

Tablets

Antihistamine - Nasal Decongestant

Each tablet contains:

Dexbrompheniramine Maleate...2 mg

Hydro PC (Phenylephrine Hydrochloride) Hydrochloride...10 mg

60 Tablets

Usual

Dosage: See product foldout for full prescribing information.

Tamper evident by foil seal under cap. Do not use if foil seal is

broken or missing.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Store at controlled room temperature between 15°-30°C (59°-86°F).

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355

Rev. 02/12

Hydro PC (Phenylephrine Hydrochloride) Tablets Packaging Hydro PC (Phenylephrine Hydrochloride) Tablets Packaging