Label: MUCINEX COLD, FLU, AND SORE THROAT- acetaminophen, guaifenesin capsule, liquid filled

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

Drug Label Information

Updated June 18, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Acetaminophen 325 mg.............Pain reliever/fever reducer
    Guaifenesin 200 mg...............................................Expectorant

  • Uses

    Uses
    ■ temporarily relieves these common cold and flu symptoms:
    ■ minor aches and pains
    ■ headache ■ sore throat
    ■ helps loosen phlegm (mucus) and thin bronchial secretions
    to rid the bronchial passageways of bothersome mucus
    and make coughs more productive
    ■ temporarily reduces fever

  • Warnings

    Liver warning: This product contains acetaminophen.
    Severe liver damage may occur if you take:
    ■ more than 12 liquid gels in 24 hours, which is the
    maximum daily amount
    ■ with other drugs containing acetaminophen
    ■ 3 or more alcoholic drinks daily while using this product
    Allergy alert: Acetaminophen may cause severe skin
    reactions. Symptoms may include:
    ■ skin reddening ■ blisters ■ rash
    If a skin reaction occurs, stop use and seek medical help right
    away.
    Sore throat warning: If sore throat is severe, persists for
    more than 2 days, is accompanied or followed by fever,
    headache, rash, nausea, or vomiting, consult a doctor
    promptly.

  • Directions

    ■ do not take more than directed (see Overdose warning)
    ■ do not take more than 12 liquid gels in any 24-hour period
    ■ adults and children 12 years of age and over: take
    2 liquid gels every 4 hours
    ■ children under 12 years of age: do not use

  • Other Information

    ■ store at 20-25°C (68-77°F)
    ■ avoid excessive heat

  • Inactive Ingredients

    FD&C blue no. 1, gelatin, glycerin, hypromellose, lecithin, light
    mineral oil, polyethylene glycol, povidone, propylene glycol,
    purified water, sorbitol sorbitan solution, titanium dioxide

  • Questions?

    1-866-MUCINEX (1-866-682-4639)

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US)
    Parsippany, NJ 07054-0224
    ©2025 RB Health

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PURPOSE

  • Principal Display Panel

    Fast Dissolving Liquid Gels!

    NDC 72854-164

    Mucinex®

    COLD, FLU, and SORE THROAT

    Acetaminophen – Pain Reliever/Fever Reducer
    Guaifenesin – Expectorant

    ✓Thins & Loosens Mucus
    ✓Relieves Sore Throat, Headache, and Body Pain

    ✓Reduces Fever


    LIQUID GELS
    (Liquid Filled Capsules)

    Actual Size

    DAY TIME
    FOR AGES 12+

    full carton label

  • INGREDIENTS AND APPEARANCE
    MUCINEX COLD, FLU, AND SORE THROAT 
    acetaminophen, guaifenesin capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-164
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    WATER (UNII: 059QF0KO0R)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize23mm
    FlavorImprint Code AR09
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-164-162 in 1 CARTON06/01/2025
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2025
    Labeler - RB Health (US) LLC (081049410)
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