POLY-TUSSIN DM- dextromethorphan hydrobromide, phenylephrine hydrochloride, chlorpheniramine maleate syrup
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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Active ingredients
(in each 5 mL teaspoonful)
Dextromethorphan Hydrobromide, USP...............................15 mg
Phenylephrine Hydrochloride, USP........................................5 mg
Chlorpheniramine Maleate, USP............................................2 mg
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
Do not exceed recommended dosage.
Do not exceed 4 doses in a 24 hour period.
Adults and children 12 years of age and over: | 2 teaspoonfuls (10 mL) every 6 hours as needed. |
Children 6 to under 12 years of age: | 1 teaspoonful (5 mL) every 6 hours as needed. |
Children 2 to under 6 years of age: | Consult a physician. |
Children under 2 years of age: | Not recommended. |
Citric Acid, FD and C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, and Strawberry Flavor.
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)
Manufactured for:
Poly Pharmaceuticals, Inc.
Mobile, AL 36619
Manufactured by:
Great Southern Laboratories
Houston, TX 77099
The packaging below represents the labeling currently used.
Principal Display Panel and Side Panel for 473 mL Label:
NDC 50991-320-16
POLY-TUSSIN DM
COUGH SYRUP
Cough Suppressant
Nasal Decongestant
Antihistamine
Sugar Free / Alcohol Free
Strawberry Flavor
Each 5 mL (one teaspoonful) for oral admininstration
contains:
Dextromethorphan Hydrobromide, USP..................15 mg
Phenylephrine Hydrochloride, USP..........................5 mg
Chlorpheniramine Maleate, USP..............................2 mg
Distributed by:
Poly Pharmaceuticals, Inc.
Mobile, AL 36619
16 fluid ounces (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 the consumer.
Distributed by: Poly Pharmaceuticals, Inc. Mobile, AL 36619
Iss. 12/09
POLY-TUSSIN
DM
dextromethorphan hydrobromide, phenylephrine hydrochloride, chlorpheniramine maleate syrup |
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Labeler - Poly Pharmaceuticals, Inc. (198449894) |