Label: POLY-TUSSIN AC- brompheniramine maleate, codeine phosphate, phenylephrine hydrochloride liquid
- NDC Code(s): 50991-723-15, 50991-723-16
- Packager: Poly Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 27, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL teaspoonful)
- Purpose
-
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
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a cough that occurs with too much phlegm
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a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
-
heart disease
-
high blood pressure
-
thyroid disease
-
diabetes
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
-
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
- Inactive ingredients
- Questions? Comments?
-
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 FreeNEW 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.
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INGREDIENTS AND APPEARANCE
POLY-TUSSIN AC
brompheniramine maleate, codeine phosphate, phenylephrine hydrochloride liquidProduct 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 unapproved drug other 06/02/2014 Labeler - Poly Pharmaceuticals, Inc. (198449894)