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 over1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24
Children 6 to under 12 years of age1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours
Children under 6 years of ageConsult 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

label

POLYTUSSIN DM 
dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50991-121
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE7.5 mg  in 5 mL
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50991-121-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/20/202108/29/2023
2NDC: 50991-121-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product10/20/202108/29/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/20/202108/29/2023
Labeler - Poly Pharmaceuticals, (198449894)

Revised: 8/2023
 

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