Label: TYLENOL COLD PLUS FLU MULTI-SYMPTOM LIQUID GELS DAY- acetaminophen, dextromethorphan hydrobromide capsule, liquid filled

  • NDC Code(s): 50580-130-24
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 26, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each capsule)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 10 mgCough suppressant
  • Uses

    • temporarily relieves these common cold/flu symptoms:
      • minor aches and pains
      • headache
      • sore throat
      • cough
      • temporarily reduces fever
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day 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.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    • liver disease
    • persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    When using this product do not exceed recommended dose

    Stop use and ask a doctor if

    ■ pain or cough gets worse or lasts more than 7 days
    ■ fever gets worse or lasts more than 3 days
    ■ redness or swelling is present ■ new symptoms occur
    ■ cough comes back or occurs with rash or headache that lasts
    These could be signs of a serious condition.

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

    Keep out of reach of children.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    adults and children 12 years and over

    ■ take 2 capsules every 4 hours while symptoms last
    ■ do not take more than 8 capsules in 24 hours

    children 4 to under 12 yearsask a doctor
    children under 4 yearsdo not use

  • Other information

    ■ store between 20-25°C (68-77°F)
    ■ avoid high humidity and excessive heat above 40°C (104°F) ■ protect from light
    ■ do not use if blister unit is torn or broken

  • Inactive ingredients

    FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

  • Questions or comments?

    call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-130-24

    TYLENOL ®

    FOR ADULTS

    COLD & FLU

    MULTI-SYMPTOM
    LIQUID GELS

    Acetaminophen,

    Dextromethorphan HBr
    Pain Reliever–Fever Reducer, Cough Suppressant

    DAY

    • HEAD + BODY ACHES
    • FEVER + SORE THROAT
    • COUGH

    *LIQUID FILLED CAPSULES

    Actual Size

    24 LIQUID GELS*

    tylenol-1

  • INGREDIENTS AND APPEARANCE
    TYLENOL COLD PLUS FLU MULTI-SYMPTOM LIQUID GELS DAY 
    acetaminophen, dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-130
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code TY;DT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-130-242 in 1 CARTON09/25/2024
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/25/2024
    Labeler - Johnson & Johnson Consumer Inc. (878046358)
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