POLYTUSSIN DM- dextromethorphan hbr, phenylephrine hcl, pyrilamine maleate syrup 
Poly Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Polytussin DM

Active ingredients

(in each 5 mL teaspoonful)

Dextromethorphan HBr............... 7.5 mg
Phenylephrine HCl....................... 5 mg
Pyrilamine Maleate................. 12.5 mg

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

Uses

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

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

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? 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).

Inactive ingredients

Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified water, Sucralose,Sorbitol

Antihistamine

Cough Suppressant

Nasal Decongestant

label

POLYTUSSIN DM 
dextromethorphan hbr, phenylephrine hcl, pyrilamine maleate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-132
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 5 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE12.5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDY (clear, colorless) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-132-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2023
2NDC:50991-132-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/08/2023
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 1/2024
Document Id: 0ff39ab1-e8c3-cad9-e063-6394a90af0eb
Set id: fda8f594-82bf-1781-e053-6294a90ad344
Version: 2
Effective Time: 20240127
 
Poly Pharmaceuticals, Inc.