Label: GUAIFENESIN tablet

  • NDC Code(s): 24689-122-01, 24689-122-02
  • Packager: APNAR PHARMA LP
  • 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 January 4, 2023

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  • BOXED WARNING (What is this?)

    Caution: do not use if imprinted seal under cap is broken or missing.

  • ACTIVE INGREDIENT

    Drug Facts
    Active Ingredient (per tablet)
    Guaifenesin USP............. 400 mg

  • PURPOSE

    Purpose
    Expectorant

  • INDICATIONS & USAGE

    Use

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

    Warnings


    Ask doctor before use if you have

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

    Stop use and ask a doctor if

    • Symptoms are accompanied by fever, rash or persistent headache
    • cough persists for more than 1 week or tends to recur
    • A persistent cough may be a sign of a serious condition

    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 overdose, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
    • Children 6 to 12 years of age: take 1/2 tablet every 4 hours as needed
    • Children under 6 years of age: consult a doctor

    Do not exceed 6 doses in a 24 hour period or as directed by a doctor

  • STORAGE AND HANDLING

    Other Information

    • store at 15°-30°C (59°-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    Microcrystalline cellulose, Croscarmellose sodium, Povidone, Silicon dioxide, magnesium stearate

  • QUESTIONS

    Questions or concerns?

    • 1-855-642-2594
  • SPL UNCLASSIFIED SECTION

    Distributed by:

    APNAR PHARMA LP

    CHINO, CA, 91710

    Rev.: 04/2022

  • PRINCIPAL DISPLAY PANEL

    APNAR PHARMA LP

    NDC : 24689-122-01

    Guaifenesin Tablets 400mg-20's Tablets

    Guaifenesin Tablets 400mg_20s Tablets

    APNAR PHARMA LP

    NDC : 24689-122-02

    Guaifenesin Tablets 400mg-500's Tablets

    Guaifenesin Tablets 400mg_500s

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-122
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (White to off White color) Score2 pieces
    ShapeROUNDSize13mm
    FlavorImprint Code LT;12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24689-122-0120 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
    2NDC:24689-122-02500 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/30/2022
    Labeler - APNAR PHARMA LP (079568229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apnar Pharma Private Limited876730408analysis(24689-122) , manufacture(24689-122)
    Establishment
    NameAddressID/FEIBusiness Operations
    APNAR PHARMA LLP118530917pack(24689-122) , label(24689-122)
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