Label: TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 12, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each capsule)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 15 mgCough suppressant
    Doxylamine Succinate 6.25 mgAntihistamine
  • Uses

    ■ temporarily relieves these common cold/flu symptoms:

    ■ minor aches and pains

    ■ headache

    ■ sore throat

    ■ cough

    ■ runny nose and sneezing

    ■ 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 containsacetaminophen, 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

    ■ glaucoma

    ■ a breathing problem such as emphysema or chronic bronchitis

    ■ trouble urinating due to an enlarged prostate gland

    ■ 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
    • taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dose
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    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 6 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

    D&C yellow no. 10, FD&C blue no. 1, 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 50580-131-24

    NEW

    TYLENOL ®
    FOR ADULTS


    COLD & FLU

    MULTI-SYMPTOM

    LIQUID GELS

    Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

    Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine

    NIGHT

    • HEAD + BODY ACHES

    • FEVER + SORE THROAT

    • COUGH

    • RUNNY NOSE

    *LIQUID FILLED CAPSULES

    Actual Size

    24 LIQUID GELS*

    tylenol-1

  • INGREDIENTS AND APPEARANCE
    TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT 
    acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-131
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code TY;NT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-131-242 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 - Kenvue Brands LLC (118772437)