Polytussin DM by Poly Pharmaceuticals, Polytussin DM

Polytussin DM by

Drug Labeling and Warnings

Polytussin DM by is a Otc medication manufactured, distributed, or labeled by Poly Pharmaceuticals,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

POLYTUSSIN DM- dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid 
Poly Pharmaceuticals,

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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Polytussin DM

Active Ingredient

Dexbrompheniramine Maleate 2 mg
Dextromethorphan Hydrobromide 15 mg
Phenylephrine Hydrochloride 7.5 mg

Purposes

Antihistamine

Antitussive
Nasal Decongestant

Uses

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
 runny nose

 sneezing
 itching of nose or throat
 itchy, watery 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 toan 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

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

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. A persistent cough may be a sign of a serious condition.

 new symptoms occur

If pregnant or breastfeeding

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

Do not exceed recommended dosage

• Adults and children 12 years of age and over: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24
• 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 24 hours
• Children under 6 years of age: Consult a doctor.

Other Information

Store at 59° - 86°F (15° - 30°C)

Inactive Ingredients

Anhydrous Citric Acid, Glycerin, Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol Solution.

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).

Package Label

POLYTUSSIN DM 
dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-121
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	7.5 mg  in 5 mL
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50991-121-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/20/2021	08/29/2023
2	NDC: 50991-121-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/20/2021	08/29/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/20/2021	08/29/2023

Labeler - Poly Pharmaceuticals, (198449894)

Revised: 8/2023

Document Id: 0412a938-bff6-139d-e063-6294a90ac9a2

34390-5

Set id: cf4c931c-d9e0-8599-e053-2995a90a2623

Version: 2

Effective Time: 20230829