Ry-Tuss Pediatric

Carbetapentane Tannate:

• Poly hist cb
• Clinical pharmacology:
• Indications and usage:
• Contraindications:
• Warnings:
• Precautions:
• Carcinogenesis, mutagenesis, and impairment of fertility:
• Pregnancy:
• Nursing mothers:
• Adverse reactions:
• Overdosage:
• Dosage and administration:
• How supplied:
• Product packaging:
• Ry-Tuss Pediatric (Carbetapentane Tannate) reviews

POLY HIST CB

Antitussive/Expectorant

Rx Only

Description: POLY HIST CB is an alcohol-free, sugar-free, purple liquid for oral administration

having a grape odor and flavor.

Each Teaspoon (5 mL) Contains:

Ry-Tuss Pediatric (Carbetapentane Tannate) CITRATE... 20 mg

GUAIFENESIN...75 mg

POLY HIST CB Liquid also contains: FD and C Blue #1, FD and C Red #40, Grape Flavor, Maltitol,

Propylene Glycol, Sodium Saccharin, Sorbitol, Purified Water.

Clinical

Pharmacology:

Ry-Tuss Pediatric (Carbetapentane Tannate) citrate is a centrally acting non-narcotic antitussive.

Guaifenesin is an expectorant. Its action increases the output of respiratory tract fluid by reducing

adhesiveness and surface tension. Sinus and bronchial drainage is improved and dry, nonproductive

coughs become more productive and less frequent.

Indications And Usage:

for temporary relief of non-productive cough accompanying respiratory tract congestion associated with

the common cold, influenza, sinusitis, and bronchitis.

Contraindications:

POLY HIST CB is contraindicated in infants and newborns, and in patients with a known

hypersensitivity to any of the components. It is also contraindicated in patients on MAO inhibitor therapy.

Warnings:

A persistent cough may be a sign of a serious condition. If cough persists for more than one week

or tends to recur, or is accompanied by fever, rash, or persistent headache, patient reevaluation

should be considered.

Precautions:

DRUG INTERACTIONS: Guaifenesin may produce an increase in urinary 5-hydroxy-indoleacetic acid and

may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. It may

also falsely elevate the VMA test for catechols. Administration of this drug should be discontinued 48 hours

prior to the collection of urine specimens for such tests.

Carcinogenesis, Mutagenesis, And Impairment of Fertility:

No adequate and well controlled studies have been conducted to determine whether the components

of POLY HIST CB have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy:

Pregnancy Category C: Animal reproduction studies have not yet been conducted with this product.

It is not known whether it can cause fetal harm when administered to a pregnant woman or can affect

reproduction capacity. This product should not be administered to pregnant women.

Nursing Mothers:

Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers.

Adverse Reactions:

Guaifenesin is well tolerated and has a wide margin of safety. Side effects are generally

mild and infrequent. Nausea and vomiting are the most common side effects. Dizziness,

headache, and rash (including urticaria) have been reported rarely.

Overdosage:

SIGNS AND SYMPTOMS: Incidence of acute toxicity with guaifenesin is low and over dosage

is unlikely to produce serious toxic effects. In laboratory animals no toxicity resulted when

guaifenesin was administered by stomach tube in doses up to 5 grams/kg.

TREATMENT: Treatment of the signs and symptoms of overdosage is symptomatic and

supportive. The patient should be induced to vomit, even if emesis has occurred spontaneously.

Pharmacologic vomiting by the administration of ipecac syrup is a preferred method, however,

vomiting should not be induced in patients with impaired consciousness. Precautions against

aspiration must be taken, especially in infants and children. Following emesis, any drug

remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water.

Dosage and Administration:

POLY HIST CB is administered orally as follows:

Adults: 1-2 teaspoonfuls every 4-6 hours or as directed by a physician.

Children 6-12 years of age: 1 teaspoonful every 4-6 hours or as directed by a physician.

Children 2-6 years of age: 1/2 teaspoonful every 4-6 hours or as directed by a physician.

Children under 2 years of age: As directed by a physician.

How Supplied:

16 fluid ounce bottles NDC # 50991-781-16 and 15 mL bottles NDC # 50991-781-15

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSAGE, CONTACT A POISON CONTROL

CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.

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

Store at controlled room temperature, 59^o-86^oF (15^o-30^oC).

DISPENSE IN TIGHT, LIGHT RESISTANT CONTAINERS WITH CHILD RESISTANT CLOSURES

AS DEFINED IN THE USP/NF.

Manufactured for:

Poly Pharmaceuticals

Mobile, AL 36619

Rx Only

Rev. 11/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

NDC 50991-781-16

Poly Hist CB

Grape Flavor

Sugar Freee Alcohol Free

Antitussive/Expectorant

Each 5 mL (1 teaspoonful) contains:

Ry-Tuss Pediatric (Carbetapentane Tannate) Citrate... 20 mg

Guaifenesin... 75 mg

Distributed by:

Poly Pharmaceuticals

Mobile, AL 36619

Rx Only

16 fl oz (473 mL)

Side Panel:

USUAL

Dosage: Adults 12 years and older: 1-2 teaspoonfuls every 4-6 hours.

Children 6-12 years of age: 1 teaspoonful every 4-6 hours. Children 2-6 years of age:

1/2 teaspoonful every 4-6 hours. Children under 2 years of age: As directed by a physician.

See package insert for complete prescribing information.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSAGE, CONTACT A POISON CONTROL

CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.

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

This bottle is not to be dispensed to consumer.

STORAGE: Store at controlled room temperature, 59^o-86^oF (15^o-30^oC).

Mfg. for: Poly Pharmaceuticals, Mobile, AL 36619

Mfg. by: Great Southern Laboratories. Houston, TX 77099

Rev. 11/09

Poly Hist CB Packaging Poly Hist CB Packaging

Chlorpheniramine Tannate:

• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Questions? comments?
• Ry-Tuss Pediatric (Chlorpheniramine Tannate) reviews

Drug Facts

Active Ingredients (in each 1 mL dropperful)	Purpose
Ry-Tuss Pediatric (Chlorpheniramine Tannate) Maleate 2 mg	Antihistamine
Phenylephrine HCl 5 mg	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 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.

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

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

Ry-Tuss Pediatric (Chlorpheniramine Tannate)

Pediatric Drops

Antihistamine ▪ Nasal Decongestant

Sugar Free ▪ Alcohol Free ▪ Gluten Free

FOR PROFESSIONAL USE ONLY

Each 1 mL for oral administration

contains:

Ry-Tuss Pediatric (Chlorpheniramine Tannate) 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)

Ephedrine Tannate:

• Boxed warning
• Active ingredient
• Purpose
• Indications
• Warnings
• Drug interaction precaution
• Ask a doctor before use if you have
• When using this product
• Stop use and ask a doctor if
• If pregnant or breast-feeding
• Keep out of reach of children.
• Directions
• Other information
• Inactive ingredients
• Manufactured by
• Label
• Ry-Tuss Pediatric (Ephedrine Tannate) reviews

Boxed Warning

FOR YOUR PROTECTION, DO NOT USE IF SEAL OVER MOUTH OF BOTTLE IS BROKEN OR MISSING. CAPUSLES ARE SEALED WITH A RED GELATIN BAND

Active ingredient

(in each capsule)

Ry-Tuss Pediatric (Ephedrine Tannate) Sulfate USP, 25 mg

Purpose

Bronchodilator

Indications

For temporary relief of shortness of breath, tightness of chest, and wheezing due to bronchial asthma. For the temporary relief of bronchial asthma. Eases breathing for asthma patients by reducing spasms of bronchial muscles.

Warnings

Do not use this product unless a diagnosis of asthma has been made by a doctor. Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Do not use this product if you have ever been hospitalized for asthma or if you are taking and prescription drug for asthma or if you are taking and prescription drug for asthma unless directed by a doctor.

Drug Interaction precaution

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (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 of pharmacist before taking this product.

Ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

When using this product

Do not use more than directed. Nervousness, tremor, sleeplessness, nausea or loss of appetite may occur. Do not continue to use this product, but seek medical assistance immediately if symptoms are not relieved within 1 hour or become worse, consult your doctor.

Stop use and ask a doctor if

Symptoms are not relieved within 1 hour or become worse. Nervousness, tremor or sleeplessness become worse. Some users of this product may experience nervousness, tremor, sleeplessness, nausea, and loss of appetite. If these symptoms persist or become worse, consult your doctor.

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

Adults and children 12 years of age and over:				Oral dosage is 12.5 to 25 milligrams every 4 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Do not exceed recommended dose unless directed by a doctor.
Children under 12 years of age:				Consult a doctor.

Other information

Store at 20-25°C (68-77°F). Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. You may report side effects to FDA at 1-800-FDA-1088.

Inactive ingredients

Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate. Capsule shell contains: FD&C Red #3 and Gelatin.

Manufactured by

West-ward Pharmaceutical Corp.

Eatontown, N.J. 07724

Label

Front

Back

Phenylephrine Tannate:

• Drug facts
• Purpose
• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Questions? comments?
• Product packaging
• Ry-Tuss Pediatric (Phenylephrine Tannate) reviews

Drug Facts

Active ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Ry-Tuss Pediatric (Phenylephrine Tannate) 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

Adults and children 12 years of age and over:	1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours
Children 6 to under 12 years of age:	1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours
Children under 6 years of age:	Consult a doctor

Other information

Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Ry-Tuss Pediatric (Phenylephrine Tannate) 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

Ry-Tuss Pediatric (Phenylephrine Tannate)

Tablets

Antihistamine - Nasal Decongestant

Each tablet contains:

Dexbrompheniramine Maleate...2 mg

Ry-Tuss Pediatric (Phenylephrine Tannate) 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

Ry-Tuss Pediatric (Phenylephrine Tannate) Tablets Packaging Ry-Tuss Pediatric (Phenylephrine Tannate) Tablets Packaging