Label: GUAIFENESIN tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 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

    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, chronic 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 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 under 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

    Maltodextrin, Povidone, Silicon dioxide and Stearic acid

  • QUESTIONS

    Questions or concerns?

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

    Manufactured by:

    APNAR PHARMA LLP

    East Windsor, NJ 08520

    Made in USA

    Rev.: 05/2022

  • PRINCIPAL DISPLAY PANEL

    NDC 24689-144-01

    Guaifenesin Tablets 400 mg

    Expectorant

    100 Tablets

    Guaifenesin Tablets 400 mg - Label - 100s

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-144
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUND (Round shaped standard concave) Size10mm
    FlavorImprint Code A;G1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24689-144-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/05/2022
    Labeler - APNAR PHARMA LP (079568229)
    Establishment
    NameAddressID/FEIBusiness Operations
    INVAHEALTH INC116840615label(24689-144) , pack(24689-144)
    Establishment
    NameAddressID/FEIBusiness Operations
    APNAR PHARMA LLP118530917manufacture(24689-144) , analysis(24689-144) , pack(24689-144)
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