Label: CHILDRENS TYLENOL COLD PLUS COUGH PLUS SORE THROAT- acetaminophen and dextromethorphan hydrobromide suspension

  • NDC Code(s): 50580-194-01
  • Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
  • 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 October 24, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)Purposes
    Acetaminophen 160 mgPain reliever/fever reducer
    Dextromethorphan HBr 5 mgCough suppressant
  • Uses

    • temporarily relieves the following 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 your child takes

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    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.
    • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
    • if your child has ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if your child has

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

    Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

    When using this product do not exceed recommended dose (see overdose warning)

    Stop use and ask a doctor if

    • pain or cough gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present
    • cough comes back or occurs with rash or headache that lasts

    These could be signs of a serious condition.

    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

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed (see overdose warning)
    • shake well before using
    • mL = milliliter
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • remove the child protective cap and squeeze your child's dose into the dosing cup
    • repeat dose every 4 hours, while symptoms last
    • do not give more than 5 times in 24 hours
    Weight (lb)Age (yr)Dose (mL)
    under 36under 4 yearsdo not use
    36-474 to 5 years5 mL
    48-956 to 11 years10 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    • store between 20-25°C (68-77°F)
    • do not use if carton is opened or if carton tape or bottle wrap imprinted "TYLENOL" is broken or missing
  • Inactive ingredients

    anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

  • Questions or comments?

    call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-194-01

    Children's
    TYLENOL®

    COLD + COUGH +
    SORE THROAT

    Acetaminophen, Pain Reliever-Fever Reducer
    Dextromethorphan HBr, Cough Suppressant

    Oral Suspension

    Ages 4-11 Years

    FEVER
    SORE THROAT
    COUGH

    4 fl oz (120 mL)

    Bubblegum
    Flavor

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    CHILDRENS TYLENOL   COLD PLUS COUGH PLUS SORE THROAT
    acetaminophen and dextromethorphan hydrobromide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-194
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen160 mg  in 5 mL
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    D&C red no. 33 (UNII: 9DBA0SBB0L)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucrose (UNII: C151H8M554)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-194-011 in 1 CARTON06/26/2017
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/26/2017
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)