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

  • NDC Code(s): 50991-492-15, 50991-492-16
  • Packager: Poly Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • 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 November 27, 2017

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

  • ACTIVE INGREDIENT

    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 DOCTOR/PHARMACIST

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

  • INDICATIONS & USAGE

    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

    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 DOCTOR

    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

    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

    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

  • 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? 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 INGREDIENT

    Inactive ingredients

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

  • PURPOSE

    Antihistamine

    Cough Suppressant

    Nasal Decongestant

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    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 Product11/22/2017
    2NDC:50991-492-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/22/2017
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
    Establishment
    NameAddressID/FEIBusiness Operations
    Monarch PCM LLC080000294manufacture(50991-492)