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POLY-TUSSIN DM

Dosage form: syrup
Ingredients: Dextromethorphan Hydrobromide 15mg in 5mL, Phenylephrine Hydrochloride 5mg in 5mL, Chlorpheniramine Maleate 2mg in 5mL
Labeler: Poly Pharmaceuticals, Inc.
NDC code: 50991-320

POLY-TUSSIN DM

Drug Facts Active ingredients
(in each 5 mL teaspoonful)
Dextromethorphan Hydrobromide, USP...............................15 mg
Phenylephrine Hydrochloride, USP........................................5 mg
Chlorpheniramine Maleate, USP............................................2 mg

PurposeCough Suppressant, Nasal Decongestant, Antihistamine

Usestemporarily 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 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
trouble urinating due to an enlarged 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)
heart disease
high blood pressure
thyroid disease
diabetes mellitus

Ask a doctor or pharmacist before use if you aretaking 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
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 this and all drugs out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions 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.

Other informationStore at controlled room temperature, 15° - 30° C (59° - 86°F).

Inactive ingredientsCitric Acid, FD and C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, and Strawberry Flavor.

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)

Manufactured for:
Poly Pharmaceuticals, Inc.
Mobile, AL 36619

Manufactured by:
Great Southern Laboratories
Houston, TX 77099

PRODUCT PACKAGINGThe 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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50991-320
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (Dextromethorphan)	Dextromethorphan Hydrobromide	15 mg in 5 mL
Phenylephrine Hydrochloride (Phenylephrine)	Phenylephrine Hydrochloride	5 mg in 5 mL
Chlorpheniramine Maleate (Chlorpheniramine)	Chlorpheniramine Maleate	2 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Citric Acid
Glycerin
Propylene Glycol
Water
Sodium Citrate
Saccharin Sodium
Sorbitol

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:50991-320-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/21/2005

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 03/2011

Document Id: c7720496-e9a6-4a60-ae62-413e258475b8

Set id: 7c7ce381-c668-4955-bab8-26ba1965a575

Version: 1

Effective Time: 20110304

Poly Pharmaceuticals, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

POLY-TUSSIN DM

Further information

See also:

Qulipta

Aimovig

Dupixent

Gemtesa

Ubrelvy

Nurtec ODT

Xeomin

Tazarotene topical

Topiramate

Dysport