POLY-TUSSIN AC- brompheniramine maleate, codeine phosphate and phenylephrine hydrochloride liquid 
Poly Pharmaceuticals, Inc.

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 AC Liquid

Drug Facts

Active ingredients                                                      
(in each 5 mL teaspoonful)
Brompheniramine Maleate 4 mg
Codeine Phosphate 10 mg
Phenylephrine Hydrochloride 7.5 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
  • 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 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
  • 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 drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • may cause or aggravate constipation
  • 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, Glycerin, Propylene Glycol, Purified Water, Raspberry Flavor, 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 (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 50991-713-16

POLY-TUSSIN AC LIQUID

Antihistamine/Antitussive/Decongestant

Alcohol Free/Dye Free

Each 5 mL (1 teaspoonful) contains:
Brompheniramine Maleate......................................4 mg
Codeine Phosphate..............................................10 mg
Phenylephrine HCl.............................................. 7.5 mg

Raspberry-Bubble Gum Flavor

CV

Rx Only

Distributed by:
Poly Pharmaceuticals
Mobile, AL  36619

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.

Manufactured by:  Great Southern Laboratories, Houston, TX  77099

Distributed for:  Poly Pharmaceuticals, Mobile, AL  36619

Rx Only

Iss. 10/09


Poly-Tussin AC Packaging




Poly-Tussin AC Packaging


POLY-TUSSIN  AC
brompheniramine maleate, codeine phosphate, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50991-713
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE4 mg  in 5 mL
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE7.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM CITRATE 
SACCHARIN SODIUM 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRY, BUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-713-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/21/200704/10/2014
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 6/2010
Document Id: 6cbaf78d-3b02-431f-8930-3622af11b709
Set id: e5a22ceb-c8b2-46ff-a8e0-df76ed12cf33
Version: 4
Effective Time: 20100616
 
Poly Pharmaceuticals, Inc.