POLYTUSSIN DM- dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl 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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Polytussin DM

Active ingredients

(in each 5 mL teaspoonful)

Dexchlorpheniramine Maleate 1 mg .............Antihistamine

Dextromethorphan HBr 10 mg ........... Cough Suppressant

Phenylephrine HCl 5 mg ....................Nasal Decongestant

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • Runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • Temporarily restores freer breathing through the nose

Warnings

Do not use 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlarged prostrate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompanied by excessive phlegm (mucus)

When using this product < do not exceed recommended dosage < marked drowsiness may occur < alcohol, sedatives, and tranquilizers may increase the drowsiness effect < avoid alcoholic beverages < use caution when driving a motor vehicle or operating machinery < excitability may occur especially in children

Stop use and ask a doctor if < cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. < symptoms do not improve within 7 days or are accompanied by fever < nervousness, dizziness, or sleeplessness 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

Adults 12 and over: 10 mL every 4 hours

Not to exceed 60 mL in 24hours

Children 6-12: 5 mL every 4 hours,

Not to exceed 30 mL in 24hrs

Children 2-6: Consult a doctor

Other information

Store at room temperature 15°C-30°C (59°F-86°F)

Questions? Call 1-800-882-1041. You may also report serious side effects to this phone number.

Professional Labeling

Take under guidance of Health Professionals.

Children 2-6 years of age: 2.5 mL every 4 hours, not to

exceed 15 mL in a 24 hour period.

Iss. 09/17

Inactive ingredients

Citric Acid Anhydrous, Cotton Candy, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sorbitol Solution, Sucralose.

Antihistamine

Cough Suppressant

Nasal Decongestant

label

POLYTUSSIN DM 
dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-492
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDY (clear, colorless) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-492-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product11/22/201704/25/2022
2NDC:50991-492-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product11/22/201705/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/22/201705/01/2022
Labeler - Poly Pharmaceuticals, Inc. (198449894)
Establishment
NameAddressID/FEIBusiness Operations
Monarch PCM LLC080000294manufacture(50991-492)

Revised: 5/2022
 
Poly Pharmaceuticals, Inc.