MUCUS RELIEF DMIMMEDIATE RELEASE IMMEDIATE RELEASE (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET [ALLEGIANT HEALTH]

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MUCUS RELIEF DMIMMEDIATE RELEASE IMMEDIATE RELEASE (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET [ALLEGIANT HEALTH]
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NDC 69168-345-07, 69168-345-26
Set ID e3774f74-ee88-48f9-9745-012ab7b8a4f5
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredient (in each tablet)

    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg

  • Purpose

    Cough suppressant
    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
  • 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 a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough accompanied by too much phlegm (mucus)

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • do not use more than directed

    Stop use and ask a 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 illness 

    If pregnant 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and children 12 years and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

    Children under 12 years of age: do not use

  • Other Information

    • store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
    • keep in a dry place and do not expose to heat n do not use if imprinted safety seal under cap is broken or missing
    • You may report side effects to 1-888-952-0050
  • Inactive Ingredients

    croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, stearic acid

  • Package/Label Principal Display Panel

    Mucus Relief

    Mucus Relief

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DMIMMEDIATE RELEASE  IMMEDIATE RELEASE
    dextromethorphan hbr and guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-345
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code AZ;345
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-345-0710 in 1 CARTON; Type 0: Not a Combination Product12/23/2014
    2NDC:69168-345-2620 in 1 CARTON; Type 0: Not a Combination Product12/23/2014
    3NDC:69168-345-98200 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/23/2014
    Labeler - Allegiant Health (079501930)
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