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

  • 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 August 4, 2023

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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
    ©2021 RB Health

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PURPOSE

  • Principal Display Panel

    Fast Dissolving Liquid Gels!

    NDC 72854-136-16

    Mucinex®

    COLD, FLU

    Acetaminophen – Pain Reliever/Fever Reducer
    Guaifenesin – Expectorant

    ✓Thins & Loosens Mucus
    ✓Relieves Sore Throat, Headache & Chest Congestion
    ✓Reduces Fever

    16
    LIQUID GELS
    (Liquid Filled Capsules)

    Actual Size

    DAY TIME
    FOR AGES 12+

    Label

  • INGREDIENTS AND APPEARANCE
    MUCINEX COLD AND FLU 
    acetaminophen, guaifenesin capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-136
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize23mm
    FlavorImprint Code AR09
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-136-162 in 1 CARTON07/01/2022
    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 finalpart34107/01/2022
    Labeler - RB Health (US) LLC (081049410)
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