Label: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE tablet

  • NDC Code(s): 24689-123-01, 24689-123-02
  • 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 Ingredients (per tablet)

    Guaifenesin USP...................................... 400 mg

    Dextromethorphan Hydrobromide USP...... 20 mg

  • PURPOSE

    Purpose

    Expectorant

    Cough suppressant

  • INDICATIONS & USAGE

    Uses:

    • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold
    • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
    • Helps make coughs more productive.
  • WARNINGS

    WARNINGS

    Do not use

    • if you are now taking a prescription Monoamine Oxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product.

    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 phegm (mucus)

    Stop use and ask a doctor if

    • Symptons 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 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 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 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 24689-123-01

    Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 20s tablets

    Guaifenesin and Hbr tablets 400+20mg- 20s tablets

    APNAR PHARMA LP

    NDC 24689-123-02

    Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 500s tablets

    Guaifenesin and Hbr tablets 400+20mg- 500s tablets

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
    guaifenesin and dextromethorphan hydrobromide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-123
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeCAPSULESize18mm
    FlavorImprint Code LT13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24689-123-0120 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
    2NDC:24689-123-02500 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(24689-123) , manufacture(24689-123)
    Establishment
    NameAddressID/FEIBusiness Operations
    APNAR PHARMA LLP118530917pack(24689-123) , label(24689-123)
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