MUCUS RELIEF IMMEDIATE RELEASE (GUAIFENESIN) TABLET [ALLEGIANT HEALTH]

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MUCUS RELIEF IMMEDIATE RELEASE (GUAIFENESIN) TABLET [ALLEGIANT HEALTH]
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NDC 69168-370-01, 69168-370-30, 69168-370-41
Set ID 221d64a2-b8c7-435a-aae4-fb58fd38108f
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredient

    Guaifenesin 400mg

  • Purpose

    Expectorant

  • Uses

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

    When using this product

    • do not exceed recommended dosage
    • do not use for more than 7 days

    Stop use and ask a doctor if

    • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    Pregnancy/Breastfeeding

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

  • Directions

    Adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

    Children under 12 years of age: do not use

  • Other information

    • store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
    • keep in a dry place and do not expose to heat
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, microcrystalline cellulose, silicon dioxide, stearic acid

  • Questions or comments?

    Call 1-888-952-0050

    Monday through Friday 9AM - PM EST.

  • Principal Display Panel

    Mucus Relief

    Mucus Relief

    Mucus Relief

    Mucus Relief


  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF  IMMEDIATE RELEASE
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-370
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize17mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-370-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2014
    2NDC:69168-370-301 in 1 CARTON12/23/2014
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69168-370-411 in 1 CARTON12/23/2014
    315 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69168-370-17300 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/23/2014
    Labeler - Allegiant Health (079501930)
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