Label: POLYTUSSIN DM- dextromethorphan hbr, phenylephrine hcl, pyrilamine maleate syrup

  • NDC Code(s): 50991-132-05, 50991-132-15, 50991-132-16
  • Packager: Poly Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 18, 2026

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients

    (in each 5 mL teaspoonful)

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

  • ASK DOCTOR/PHARMACIST

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

  • INDICATIONS & USAGE

    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

    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 DOCTOR

    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
  • WHEN USING

    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

    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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in 24 hours

    Children 6 to under 12 years of age:1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours

    Children under 6 years of age: Consult a doctor

  • OTHER SAFETY INFORMATION

    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 INGREDIENT

    Inactive ingredients

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

  • PURPOSE

    Antihistamine

    Cough Suppressant

    Nasal Decongestant

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    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
    3NDC:50991-132-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product08/18/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/08/2023
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
    Establishment
    NameAddressID/FEIBusiness Operations
    BEO Pharma Inc105153330manufacture(50991-132)
    Establishment
    NameAddressID/FEIBusiness Operations
    Belleview Bioscience LLC131968803manufacture(50991-132)