Label: MUCUS RELIEF- guaifenesin tablet

  • NDC Code(s): 57896-794-01, 57896-794-03, 57896-794-06
  • Packager: Geri-Care Pharmaceuticals, Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 2, 2024

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  • Active ingredient (in each tablet)

    Guaifenesin 400 mg

  • Purpose

    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageways 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)

    Stop use and ask a doctor if

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

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take with full glass of water
    • do not exceed recommended dose
    adults and children 12 years
    of age and over
    		1 tablet, every 4 hours, while
    symptoms persist • do not
    exceed 6 doses in 24 hours
    children under 12 years of age
    		do not use

  • Other information

    • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing.

    • store at 20°-25°C(68°-77°F); excursions permitted between 15°C- 30°C (59°F - 86°F)

  • Inactive ingredients

    cellulose, magnesium stearate, maltodextrin, povidone, silica, sodium starch glycolate, stearic acid.

  • Questions or comments?

    1-800-540-3765

  • package Label

    1

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-794
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code TCL272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-794-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2012
    2NDC:57896-794-0330 in 1 BOTTLE; Type 0: Not a Combination Product01/01/201208/01/2013
    3NDC:57896-794-0660 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/01/2004
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Registrant - Geri-Care Pharmaceuticals, Corp (611196254)
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