Label: SIMPEX GUAIFENESIN- guaifenesin tablet

  • NDC Code(s): 76457-004-00
  • Packager: Simpex Pharma Pvt. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • Drug Facts


  • 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 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 with excessive phlegm (mucus)

    Stop use and ask a doctor if

    • cough lasts more than 7 days, recurs, or is accompanied with fever, rash, or persistent headache.These could be signs of a serious condition. 

    If pregnant or breast-feeding,

    ask a health care 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

    • adults & children 12 years of age and older : take a 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

    • preserve in tight containers at a temperature not exceeding 30°C.
  • Inactive ingredients

    colloidal anhydrous silica, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, pregelatinised starch, sodium starch glycolate type A, stearic acid

  • Package Labeling:

    Label4

  • INGREDIENTS AND APPEARANCE
    SIMPEX GUAIFENESIN  
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76457-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorred (Iron oxide red, Iron oxide yellow) Scoreno score
    ShapeROUND (Biconvex) Size6mm
    FlavorImprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76457-004-00100 in 1 CARTON; Type 0: Not a Combination Product02/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/09/2018
    Labeler - Simpex Pharma Pvt. Ltd (916758275)
    Establishment
    NameAddressID/FEIBusiness Operations
    Simpex Pharma Pvt. Ltd916758275manufacture(76457-004)
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