Label: GUAIFENESIN 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 24, 2021

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each immediate-release tablet)

    Guaifenesin 400 mg

  • PURPOSE

    Purpose

    Expectorant

  • INDICATIONS & USAGE

    Uses

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

    Warnings

  • ASK DOCTOR

    Ask a doctor before use if you have

    • persistant or chronic cough such as occurs with smoking , asthma, chronic bronchitis, or emphysema
    • cough accompanied by excessive phlegm (mucus)
  • WHEN USING

    When using this product

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

  • STOP USE

    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.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a healthcare 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 (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    Other information

    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°- 86°F)
    • keep in a dry place and do not expose to excessive heat
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments? Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    272R-Rite Aid-Mucus Relief-bottle label-30s272R-Rite Aid-Mucus Relief-carton label-30s

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7836
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code TCL272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-7836-51 in 1 CARTON12/27/2021
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/27/2021
    Labeler - RITE AID (014578892)
    Registrant - TIME CAP LABORATORIES INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LTD.925822975manufacture(11822-7836)
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