Label: PHARBINEX- guaifenesin 400mg 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 January 31, 2022

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  • Active ingredient (in each tablet)

    Guaifenesin 400 mg

  • Purpose

    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
    • helps make cough more productive
  • 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 by too much phlegm (mucus)
  • Stop use and ask a doctor if

    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

    These could be sings of a serious illness.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • take with a full glass of water
    • this product can be administered without regard for the timing of the meals
    • do not exceed 6 doses in 24 hours or as directed by a doctor
     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 ½ tablet every 4 hours as needed
     children under 6 years of age ask a doctor

  • Other information

    store at 20 0- 25 0C (68 0-77 0F)

  • Inactive ingredients

    magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

  • Questions?

    (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of registered trademark Mucinex ®

    Distributed by:

    ULAI HEALTH LLC.

    Alexandria, VA 22312

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 73057-379-04

    Manufactured in the USA

    Immediate Release

    PHARBINEX

    *Compare to the active ingredient in Mucinex ® Tablets

    Guaifenesin 400mg

    Expectorant

    30 TABLETS

    ULAI PHARBINEX 30CT. LABEL

  • INGREDIENTS AND APPEARANCE
    PHARBINEX 
    guaifenesin 400mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73057-379
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeCAPSULESize18mm
    FlavorImprint Code PH063
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73057-379-0430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/26/2019
    Labeler - Ulai Health LLC (081181535)
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