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DRUGS & SUPPLEMENTS
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How is the drug helping you? |
Chlorpheniramine Maleate:
Drug Facts
Active Ingredients (in each 1 mL dropperful) | Purpose |
---|---|
Vasofrinic DH (Chlorpheniramine Maleate) Maleate 2 mg | Antihistamine |
Phenylephrine HCl 5 mg | Nasal Decongestant |
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies
Do not exceed recommended dosage.
Ask a doctor before use if a child is taking sedatives or tranquilizers
Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Do not exceed recommended dosage.
Children 6 to under 12 years of age: | 1 mL (1 dropperful) every 4 hours, not to exceed 6 mL in 24 hours or as directed by a doctor |
Children 2 to under 6 years of age: | 0.5 mL (1/2 dropperful) every 4 hours, not to exceed 3 mL in 24 hours, or as directed by a doctor |
Children under 2 years of age: | Consult a doctor |
Store at 59°-86°F (15°-30°C)
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
Call 1-800-543-9560
Rev. 05/11
E
NEW
FORMULA
NDC 00485-0096-02
Vasofrinic DH (Chlorpheniramine Maleate)
Pediatric Drops
Antihistamine ▪ Nasal Decongestant
Sugar Free ▪ Alcohol Free ▪ Gluten Free
FOR PROFESSIONAL USE ONLY
Each 1 mL for oral administration
contains:
Vasofrinic DH (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 Bitartrate:
Vasofrinic DH (Hydrocodone Bitartrate) 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 .
Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is a combination product containing an opioid antitussive and expectorant indicated for:
Important Limitations of Use:
Not indicated for pediatric patients under 18 years of age. ( 8.4)
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 Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution with an accurate milliliter measuring device. ( 5.10)
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 Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution by the oral route only. Measure Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose .
Oral Solution:
Each 5 mL contains Vasofrinic DH (Hydrocodone Bitartrate) bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg .
Oral Solution: Each 5 mL contains Vasofrinic DH (Hydrocodone Bitartrate) bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg.( 3)
Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is contraindicated in:
Concomitant use of opioids, including Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is used with benzodiazepines, alcohol, or other CNS depressants .
Vasofrinic DH bitartrate, one of the active ingredients in Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution, produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Overdose of Vasofrinic DH (Hydrocodone Bitartrate) bitartrate in adults has been associated with fatal respiratory depression, and the use of Vasofrinic DH (Hydrocodone Bitartrate) bitartrate in children less than 6 years of age has been associated with fatal respiratory depression. Exercise caution when administering Vasofrinic DH (Hydrocodone Bitartrate) 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 .
Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution. Prescribe and administer Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution with the same degree of caution appropriate to the use of other opioid drugs .
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 Vasofrinic DH Oral Solution should be avoided in these patients.
Vasofrinic DH (Hydrocodone Bitartrate) bitartrate, one of the active ingredients in Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution. Concurrent use of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution with alcohol or other central nervous system depressants should be avoided because additional impairment of central nervous system performance may occur.
Vasofrinic DH Oral Solution should be used with caution in patients with acute abdominal conditions since the administration of Vasofrinic DH (Hydrocodone Bitartrate) may obscure the diagnosis or clinical course of patients with acute abdominal conditions. The concurrent use of other anticholinergics with Vasofrinic DH (Hydrocodone Bitartrate) may produce paralytic ileus .
The concurrent use of anticholinergics with Vasofrinic DH (Hydrocodone Bitartrate) may produce paralytic ileus. Exercise caution when using Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution in patients taking anticholinergic medications .
Vasofrinic DH 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 Vasofrinic DH (Hydrocodone Bitartrate) bitartrate may increase the effect of either the antidepressant or Vasofrinic DH (Hydrocodone Bitartrate) .
Vasofrinic DH (Hydrocodone Bitartrate) 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).
Patients should be advised to measure Vasofrinic DH 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.
Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution should be used with caution in patients with diabetes, thyroid disease, Addison's disease, prostatic hypertrophy or urethral stricture, and asthma.
Vasofrinic DH Oral Solution should be used with caution in patients with severe renal impairment.
Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution should be used with caution in patients with severe hepatic impairment .
Use of Vasofrinic DH (Hydrocodone Bitartrate) bitartrate is associated with the following:
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 Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate) 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.
No specific interaction studies have been conducted with Vasofrinic DH Oral Solution.
The use of benzodiazepines, opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants concomitantly with Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution may cause an additive CNS depressant effect, profound sedation, respiratory depression, coma, and death and should be avoided .
Do not prescribe Vasofrinic DH 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 Vasofrinic DH (Hydrocodone Bitartrate) preparations may increase the effect of either the antidepressant or Vasofrinic DH (Hydrocodone Bitartrate) .
Vasofrinic DH (Hydrocodone Bitartrate) should be administered cautiously to persons receiving anticholinergic drugs in order to avoid paralytic ileus and excessive anticholinergic effects .
Teratogenic Effects: Pregnancy Category C
There are no adequate and well controlled studies of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution in pregnant women. Reproductive toxicity studies have not been conducted with Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution; however, studies are available with an individual active ingredient or related active ingredient. Vasofrinic DH (Hydrocodone Bitartrate) was teratogenic in hamsters. Codeine, an opiate related to Vasofrinic DH (Hydrocodone Bitartrate), increased resorptions and decreased fetal weight in rats. Because animal reproduction studies are not always predictive of human response, Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution should be used during pregnancy only if the benefit justifies the potential risk to the fetus.
Vasofrinic DH (Hydrocodone Bitartrate):
Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate). In a study in which pregnant rats were dosed throughout organogenesis, a dose of codeine approximately 40 times the MRHDD of Vasofrinic DH (Hydrocodone Bitartrate) (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 Vasofrinic DH (Hydrocodone Bitartrate) (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.
As with all opioids, administration of Vasofrinic DH 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.
Caution should be exercised when Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is administered to nursing mothers. Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate) 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.
Safety and effectiveness of Vasofrinic DH Oral Solution in pediatric patients under 18 years of age has not been established. The use of Vasofrinic DH (Hydrocodone Bitartrate) in children less than 6 years of age is associated with fatal respiratory depression .
Clinical studies have not been conducted with Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution in geriatric populations. Other reported clinical experience with the individual active ingredients of Vasofrinic DH (Hydrocodone Bitartrate) 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.
Vasofrinic DH Oral Solution should be given with caution in patients with severe impairment of renal function.
Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution should be given with caution in patients with severe impairment of hepatic function.
Vasofrinic DH Oral Solution is a Schedule II controlled prescription containing Vasofrinic DH (Hydrocodone Bitartrate) bitartrate and should be prescribed and administered with caution.
Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate) 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.
Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, Vasofrinic DH (Hydrocodone Bitartrate) 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.
No human overdosage data are available for Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution.
Vasofrinic DH (Hydrocodone Bitartrate):
Overdosage with Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate). 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.
Vasofrinic DH Oral Solution contains Vasofrinic DH (Hydrocodone Bitartrate) bitartrate (a centrally-acting opioid antitussive) and guaifenesin (an expectorant).
Each 5 mL dose of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution contains: Vasofrinic DH (Hydrocodone Bitartrate) bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg.
Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution also contains: artificial raspberry flavor, citric acid, glycerin, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, and saccharin sodium.
Vasofrinic DH (Hydrocodone Bitartrate) 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
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
Vasofrinic DH is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of Vasofrinic DH (Hydrocodone Bitartrate) and other opiates is not known; however, Vasofrinic DH (Hydrocodone Bitartrate) is believed to act directly on the cough center. In excessive doses, Vasofrinic DH (Hydrocodone Bitartrate) will depress respiration. Vasofrinic DH (Hydrocodone Bitartrate) 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.
Systemic exposure (in terms of peak plasma concentrations and area under plasma concentration versus time curve) of Vasofrinic DH (Hydrocodone Bitartrate) bitartrate and guaifenesin after single dose administration of 10 mL Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution are equivalent to respective reference solutions of 5 mL Vasofrinic DH (Hydrocodone Bitartrate) bitartrate (5 mg/5 mL), and 10 mL guaifenesin (200 mg/5 mL).
Vasofrinic DH (Hydrocodone Bitartrate): Following a single 10 mL oral dose of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution administered to 36 healthy adults (19-74 years), the geometric mean C max and AUC 0-inf for Vasofrinic DH (Hydrocodone Bitartrate) were 12.6 ng/ml and 80.9 ng·hr/ml, respectively. The median time to maximum concentration for Vasofrinic DH (Hydrocodone Bitartrate) was about 1.25 hours. Food has no significant effect on the extent of absorption of Vasofrinic DH (Hydrocodone Bitartrate). The mean plasma half-life of Vasofrinic DH (Hydrocodone Bitartrate) is approximately 5 hours.
Guaifenesin: Following a single 10 mL oral dose of Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate) were administered in combination, the pharmacokinetics for each component were similar to those observed when each component was administered separately.
Carcinogenicity, mutagenicity, and reproductive studies have not been conducted with Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution; however, published information is available for the individual active ingredients or related active ingredients.
Vasofrinic DH (Hydrocodone Bitartrate):
Carcinogenicity studies were conducted with codeine, an opiate related to Vasofrinic DH (Hydrocodone Bitartrate). 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 Vasofrinic DH (Hydrocodone Bitartrate) on a mg/m 2 basis).
Guaifenesin:
Carcinogenicity, genotoxicity, or reproductive toxicology studies have not been conducted with guaifenesin
Efficacy studies were not conducted with Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution. Efficacy of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is based on demonstration of bioequivalence to the individual comparator products .
Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is supplied as a clear, raspberry flavored liquid containing 2.5 mg Vasofrinic DH (Hydrocodone Bitartrate) 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.
Overdosage
Advise patients not to increase the dose or dosing frequency of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution because serious adverse events such as respiratory depression may occur with overdosage .
Dosing
Advise patients to measure Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution is used with benzodiazepines or other CNS depressants, including alcohol.
Because of this risk, patients should avoid concomitant use of Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution may produce marked drowsiness .
Drug Dependence
Caution patients that Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution contains Vasofrinic DH (Hydrocodone Bitartrate) 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
Vasofrinic DH Oral Solution (Oh-brĕ-don Oral Solution)
(hydrocodone bitartrate and guaifenesin) Each 5 mL contains Vasofrinic DH (Hydrocodone Bitartrate) bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg. C-II
What is the most important information I should know about Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?
What is Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?
Who should not take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?
Before you take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution with certain other medicines can cause side effects or affect how well Vasofrinic DH (Hydrocodone Bitartrate) 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:
How should I take Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?
What should I avoid while taking Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?
What are the possible side effects of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?
Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution may cause serious side effects, including:
The most common side effects of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution include:
These are not all the possible side effects of Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?
General information about the safe and effective use of Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution for a condition for which it was not prescribed. Do not give Vasofrinic DH (Hydrocodone Bitartrate) 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 Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution that is written for health professionals.
What are the ingredients in Vasofrinic DH (Hydrocodone Bitartrate) Oral Solution?
Active ingredients: Vasofrinic DH (Hydrocodone Bitartrate) 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
Pseudoephedrine Hydrochloride:
Active ingredients (in each caplet)...Purpose
Guaifenesin 400 mg...Expectorant
Vasofrinic DH (Pseudoephedrine Hydrochloride) hydrochloride 60 mg...Nasal decongestant
Uses
For temporarily relief of nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis), and to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Uses
Warnings
Do not exceed recommended dosage.
Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Ask a doctor before use if you have
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a poison control center immediately.
Directions
Inactive ingredients
croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and starch
Questions?
1-800-324-1880, 7:30am - 4:00pm Central, Mon.-Fri., or visit us at www.bfascher.com
Depending on the reaction of the Vasofrinic DH after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Vasofrinic DH not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Vasofrinic DH addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology