MUCUS RELIEF IMMEDIATE RELEASE (GUAIFENESIN) TABLET [ALLEGIANT HEALTH]

MUCUS RELIEF IMMEDIATE RELEASE (GUAIFENESIN) TABLET [ALLEGIANT HEALTH]
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NDC 69168-330-01, 69168-330-17, 69168-330-30, 69168-330-41
Set ID 9f384bbe-077d-47da-866d-9b29d1bbe8d9
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredient

    Guaifenesin 400mg

  • Purpose

    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus
  • Warnings

    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 excessive phlegm (mucus)

    When using this product

    • do not exceed recommended dosage
    •  do not use for more than 7 days

    Stop use and ask a doctor if

    • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • If pregnant or breast-feeding,

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

  • 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 of age 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
    • 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

    magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

  • Package/Label Principal Display Panel

     Health A2Z®

    Immediate release

    MUCUS RELIEF

    Guaifenesin 400mg

    EXPECTORANT

    • Relieves Chest Congestion
    • Thins and Loosens Mucus

    TABLETS

    Guaifenesin 400mg

    Guaifenesin 400mg

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF  IMMEDIATE RELEASE
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-330
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize17mm
    FlavorImprint Code TCL272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-330-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2014
    2NDC:69168-330-17300 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2014
    3NDC:69168-330-3030 in 1 CARTON; Type 0: Not a Combination Product12/23/2014
    4NDC:69168-330-4115 in 1 CARTON; 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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