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

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

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.

Drug Label Information

Updated January 27, 2024

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  • 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.

  • 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
  • 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 breastfeeding 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

    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 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/08/2023
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
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