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Pill Identifier Information of Mucinex 600 MG 12 HR Extended Release Tablet

Drug Information

Mucinex 600 MG 12 HR Extended Release Tablet

Imprint: Mucinex;600
Shape: C48345
Color: C48325
Ingredients: Guaifenesin
Size: 16.00
Score: 1
Rxtty: SY
Author: Atlantic Biologicals Corps
Inactive Ingredients: CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) / FD&C BLUE NO. 1 / ALUMINUM OXIDE / HYPROMELLOSES / MAGNESIUM STEARATE / CELLULOSE, MICROCRYSTALLINE>

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each extended-release bi-layer tablet)

    Guaifenesin 600 mg

  • Purpose

    Expectorant

  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make 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.

ask a health professional before use. If pregnant or breast-feeding,

In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

  • 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 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
    • children under 12 years of age: do not use
  • Other information

    • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
    • store between 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

  • Questions?

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

    To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to this phone number: 1-866-MUCINEX (1-866-682-4639)

  • SPL UNCLASSIFIED SECTION

    Dist. by:

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

  • MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE

    1

  • INGREDIENTS AND APPEARANCE
    MUCINEX 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0008(NDC:63824-008)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (blue and white) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code Mucinex;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0008-21 in 1 BLISTER PACK; Type 0: Not a Combination Product06/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02128207/03/2012
    Labeler - ATLANTIC BIOLOGICAS CORP. (047437707)