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
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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
-
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
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. -
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)