POLY-TUSSIN AC- brompheniramine maleate, codeine phosphate, phenylephrine hydrochloride liquid

Poly-Tussin AC by

Drug Labeling and Warnings

Poly-Tussin AC by is a Otc medication manufactured, distributed, or labeled by Poly Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL teaspoonful) 

Brompheniramine Maleate 4 mg
Codeine Phosphate 10 mg
Phenylephrine Hydrochloride 10 mg

Purpose

Antihistamine
Antitussive
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, water 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

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

• 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
• may cause or aggravate constipation
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

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.  These could be signs of a serious condition.

• new symptoms occur

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the 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 over 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed ; 6 teaspoonfuls in a 24 hour period.
• Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed ; 3 teaspoonfuls in a 24 hour period.
• Children under 6 years of age: Not recommended for use.

Other information

Store at 59° - 86°F(15° - 30°C)

Inactive ingredients

Bubble gum flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, raspberry flavor, sorbitol, sucralose.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number.  Call 1-800-882-1041
Mon - Fri (8a.m. to 5 p.m. CST)

Product Packaging:

Packaging below represents label currently used:

Principal display panel and side panel for 473 mL label:

NDC: 50991-723-16

POLY-TUSSIN AC LIQUID

Antihistamine/Antitussive/Decongestant
Alcohol Free/Dye Free

NEW FORMULA
Each 5 mL (1 teaspoonful) contains:
Brompheniramine Maleate......................................4 mg
Codeine Phosphate..............................................10 mg
Phenylephrine HCl.............................................. 10 mg

Raspberry-Bubble Gum Flavor

CV

Rx Only

Distributed by:
Poly Pharmaceuticals
Huntsville, AL  35763

16 fl oz. (473 mL)

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 closure.

This bottle is not to be dispensed to consumer.

INGREDIENTS AND APPEARANCE

POLY-TUSSIN AC 
brompheniramine maleate, codeine phosphate, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-723
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	4 mg  in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY, BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50991-723-15	12 in 1 TRAY	06/02/2014
1		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 50991-723-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/02/2014

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Establishment
Name	Address	ID/FEI	Business Operations
TG United		172837085	manufacture(50991-723)