POLY-TUSSIN- chlorcyclizine hydrochloride, codeine phosphate 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.
----------
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)
Uses
Temporarily 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
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
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.
Inactive ingredients
Cherry 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 Packaging
The 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 |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| Labeler - Poly Pharmaceuticals, Inc. (198449894) |