POLY-TUSSIN

Dosage form: liquid
Ingredients: Chlorcyclizine Hydrochloride 9.375mg in 5mL, Codeine Phosphate 10mg in 5mL
Labeler: Poly Pharmaceuticals
NDC Code: 50991-119

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.

POLY-TUSSIN LIQUID

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

Chlorcyclizine Hydrochloride 9.375 mg
Codeine Phosphate 10 mg
(WARNING:  May be habit forming)

PurposeAntihistamine
Antitussive

UsesTemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, water eyes
  • cough due to minor throat and bronchial irritation

Warnings

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

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
  • cough 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
Adults and children
12 years of age
and over:

2 teaspoonful (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 teaspoonful 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 higher dose than recommended by a doctor could result in serious side effects for your child.

Other informationStore at 59° - 86°F (15° - 30­°C).

Inactive ingredientsCherry 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).

CV

Product PackagingThe packaging below represents the labeling currently used.

Principal display label and side panel for 473 mL label:

NDC 50991-119-16

POLY-TUSSIN
LIQUID     

Patent Pending

Antihistamine · Antitussive

Sugar Free / Alcohol Free / Dye Free / Gluten Free

Each 5 mL (1 teaspoonful) contains:

Chlorcylizine HCl............................9.375 mg
Codeine Phosphate.............................10 mg
(WARNING:  May be habit forming)

Cherry Flavor

CV

Distributed by:
Poly Pharmaceuticals
Quitman, MS  39355

16 fl oz. (473 mL)

The labeling for this product contains 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 
chlorcyclizine hydrochloride, codeine phosphate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-119
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorcyclizine Hydrochloride (Chlorcyclizine) Chlorcyclizine Hydrochloride9.375 mg  in 5 mL
Codeine Phosphate (Codeine Anhydrous) Codeine Phosphate10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium Dihydrate 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50991-119-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/18/2012
Labeler - Poly Pharmaceuticals (198449894)
Registrant - Great Southern Laboratories (056139553)
Establishment
NameAddressID/FEIOperations
Great Southern Laboratories056139553manufacture(50991-119)

Revised: 09/2012
 
Poly Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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