POLY-TUSSIN D- chlorcyclizine hydrochloride, codeine phosphate, pseudoephedrine hydrochloride liquid
Poly Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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POLY-TUSSIN D

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Chlorcyclizine Hydrochloride 9.375 mg

Codeine Phosphate 10 mg

(WARNING: May be habit forming)

Pseudoephedrine Hydrochloride 30 mg

Purpose

Antihistamine

Antitussive

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
cough due to minor throat and bronchial irritation
nasal congestion
reduces swelling of the nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

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 or pharmacist before taking this product.

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to the enlargement of the prostate gland
a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm (mucus)
a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
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 marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase the drowsiness effect
be careful when driving a motor vehicle or operating machinery
may cause or aggravate constipation

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
new symptoms occur

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

Do not exceed recommended dosage.

Adults and children 12 years of age and over:	2 teaspoonfuls (10 mL) every 6 to 8 hours, not to exceed 8 teaspoonfuls in 24 hours.
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 6 to 8 hours, not to exceed 4 teaspoonfuls in 24 hours.
Children under 6 years of age:	Consult a doctor.

A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
Giving a high dose than recommended by a doctor could result in serious side effects for your child.

Other information

Store at 59° - 86°F (15° - 30°C).

Inactive ingredients

Berry Vanilla Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041

Mon - Fri (8 a.m. to 5 p.m. CST).

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 473 mL label:

NDC 50991-114-16

POLY-TUSSIN D

LIQUID

Patent Pending

Antihistamine · Antitussive

Sugar Free / Alcohol Free / Dye Free / Gluten Free

Each 5 mL (1 teaspoonful) contains:

Chlorcyclizine HCl..........................................9.375 mg

Codeine Phosphate.............................................10 mg

(WARNING: May be habit forming)

Pseudoephedrine HCl..........................................30 mg

Berry Vanilla Flavor

Distributed by:

Poly Pharmaceuticals

Quitman, MS 39355

16 fl oz. (473 mL)

The labeling for this product includes professional labeling which is not intended for use by the general public.

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

Dispense in a tight, light-resistant container with a child-resistant cap.

THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.

Manufactured by: Great Southern Laboratories, Houston, TX 77099

Distributed for:Poly Pharmaceuticals, Quitman, MS 39355

Iss. 07/12

Patent Pending

POLY-TUSSIN D Labeling

POLY-TUSSIN D
chlorcyclizine hydrochloride, codeine phosphate, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50991-114
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORCYCLIZINE HYDROCHLORIDE (UNII: NPB7A7874U) (CHLORCYCLIZINE - UNII:M26C4IP44P)	CHLORCYCLIZINE HYDROCHLORIDE	9.375 mg in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY (Berry Vanilla)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50991-114-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2012	02/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/18/2012	02/01/2018

Labeler - Poly Pharmaceuticals (198449894)

Revised: 2/2018

Document Id: 64a829fe-e604-e21e-e053-2991aa0a7cb2

Set id: fa1979f3-7789-45c1-9527-899a1bcb6dae

Version: 2

Effective Time: 20180207

Poly Pharmaceuticals