Label: POLY-TUSSIN DM- dextromethorphan hydrobromide, phenylephrine hydrochloride, chlorpheniramine maleate syrup

  • NDC Code(s): 50991-320-16
  • Packager: Poly Pharmaceuticals, Inc.
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 4, 2011

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

  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)

    Dextromethorphan Hydrobromide, USP...............................15 mg
    Phenylephrine Hydrochloride, USP........................................5 mg
    Chlorpheniramine Maleate, USP............................................2 mg

  • Purpose

    Cough Suppressant, Nasal Decongestant, Antihistamine
  • Uses

    temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, water 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 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 mellitus

    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 drowsiness
    • 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.  These could be signs of a serious condition.
    • new symptoms occur

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep this and all drugs out of the reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.
  • Directions

    Do not exceed 4 doses in a 24 hour period.
    Adults and children
    12 years of age and over:
    2 teaspoonfuls (10 mL)
    every 6 hours as needed.
    Children 6 to under 12 years
    of age:
    1 teaspoonful (5 mL)
    every 6 hours as needed.
    Children 2 to under 6 years
    of age:
    Consult a physician.

    Children under 2 years
    of age:
    Not recommended.

  • Other information

    Store at controlled room temperature, 15° - 30° C (59° - 86°F).
  • Inactive ingredients

    Citric Acid, FD and C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, and Strawberry Flavor.
  • 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)

    Manufactured for:
    Poly Pharmaceuticals, Inc.
    Mobile, AL  36619

    Manufactured by:
    Great Southern Laboratories
    Houston, TX  77099

    The packaging below represents the labeling currently used.

    Principal Display Panel and Side Panel for 473 mL Label:

    NDC 50991-320-16



    Cough Suppressant
    Nasal Decongestant

    Sugar Free /  Alcohol Free

    Strawberry Flavor

    Each 5 mL (one teaspoonful) for oral admininstration
    Dextromethorphan Hydrobromide, USP..................15 mg
    Phenylephrine Hydrochloride, USP..........................5 mg
    Chlorpheniramine Maleate, USP..............................2 mg

    Distributed by:
    Poly Pharmaceuticals, Inc.
    Mobile, AL  36619

    16 fluid ounces (473 mL)

    Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

    Dispense in a tight, light-resistant container with a child-resistant closure.

    This bottle is not to be dispensed to the consumer.

    Distributed by:  Poly Pharmaceuticals, Inc. Mobile, AL  36619

    Iss. 12/09

    Poly-Tussin DM Packaging

    Poly-Tussin DM Packaging

    dextromethorphan hydrobromide, phenylephrine hydrochloride, chlorpheniramine maleate syrup
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50991-320
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 15 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg  in 5 mL
    Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate 2 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Citric Acid (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor STRAWBERRY Imprint Code
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50991-320-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/21/2005
    Labeler - Poly Pharmaceuticals, Inc. (198449894)