Label: CHEST CONGESTION RELIEF- guaifenesin and dextromethorphan hbr tablet

  • 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 December 18, 2016

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

  • Active Ingredient

    (in each intermediate release tablet)

    Guaifenesin 400 mg

    Dextromethorphan HBr 20 mg

    Close
  • Purpose

    Expectorant

    Cough Suppressant

    Close
  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
    • helps loosen phelgm (mucus) and thin bronchial secretions to make coughs more productive
    Close
  • 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 your prescription drug contains an MAOI ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • cough accompanied by too much of phelgm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • when using this product do not use more than directed

    Stop use and ask doctor if

    Cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache, these could be signs of a serious condition.

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

    Close
  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

    Close
  • Directions

    • take with full glass of water;

      1 tablet every 4 hours

    • do not take more than 6 tablets in 24 hours
    • children under 12 years: do not use
    Close
  • Other Information

    • store at 25° C(77°F) ; excursion permitted between 15°-30° C (59°-86°F)
    • see end flap for expiration date and lot number
    • metal content per tablet:
    • sodium 7mg, Magnesium 1mg
    Close
  • Inactive Ingredients

    Colloidal Silicon Dioxide, Hypromellose, Microcrystalline cellulose, Magnesium stearate, Polyethylene Glycol, Stearic Acid powder, Sodium Starch Glycolate

    Close
  • Questions or Comments

    Call 1-855-314-1850

    Close
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    66014619-figure-01
    66014619-figure-02

    NDC 62011-0319-1

    Close
  • INGREDIENTS AND APPEARANCE
    CHEST CONGESTION RELIEF 
    guaifenesin and dextromethorphan hbr tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0319
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 16mm
    Flavor Imprint Code TCL;280
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62011-0319-1 50 in 1 BOTTLE 11/25/2016
    1 1 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/25/2016
    Labeler - Mckesson (177667227)
    Close