MUCUS RELIEF EXTENDED RELEASE MAXIMUM STRENGTH (GUAIFENESIN) TABLET [CARDINAL HEALTH (LEADER) 70000]

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MUCUS RELIEF EXTENDED RELEASE MAXIMUM STRENGTH (GUAIFENESIN) TABLET [CARDINAL HEALTH (LEADER) 70000]
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NDC 70000-0479-1, 70000-0479-2
Set ID 54a59e95-f95a-4bcd-ac9d-8d4ace85277f
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health (Leader) 70000
Generic Name
Product Class
Product Number
Application Number ANDA207342
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  • Active ingredient (in each extended-release tablet)

    Guaifenesin 1200 mg

  • Purpose

    Expectorant

  • Uses

    Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.

  • Warnings

    Do not use

    for children under 12 years of age.

    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 signs 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

    • do not crush, chew, or break tablet
    • take with a full glass of water
    • this product can be administered without regard for the timing of meals
    • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
    • children under 12 years of age: do not use 
  • Other information

    • store between 20º to 25ºC (68º to 77ºF)
  • Inactive ingredients

    carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    COMPARE TO MUCINEX® MAXIMUM STRENGTH active ingredient*

    Maximum Strength

    Mucus Relief

    Guaifenesin, 1200 mg | Expectorant

    12-Hour Relief

    Relieves Chest Congestion

    Thins and Loosens Mucus

    EXTENDED-RELEASE TABLETS

    *This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Maximum Strength Mucinex®.

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN OHIO 43017

    www.myleader.com

  • Package Label

    Guaifenesin 1200 mg

    LEADER Maximum Strength Mucus Relief

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF EXTENDED RELEASE  MAXIMUM STRENGTH
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0479
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code AN037
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0479-114 in 1 CARTON01/31/2019
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70000-0479-228 in 1 CARTON01/31/2019
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20734201/31/2019
    Labeler - Cardinal Health (Leader) 70000 (063997360)
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