Label: CHILDRENS PAIN AND FEVER- acetaminophen suspension

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

Drug Label Information

Updated May 15, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily:

    • reduces fever
    • relieves minor aches and pains due to:
      • the common cold
      • flu
      • headache
      • sore throat
      • toothache
  • 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.
    • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if your child has liver disease.

    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 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

    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 24under 2 yearsAsk a doctor
    24-352-3 years5 mL 
    36-474-5 years7.5 mL 
    48-596-8 years10 mL 
    60-719-10 years12.5 mL 
    72-9511 years15 mL 

    *or as directed by a doctor

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

  • Other information

    • each 5 mL contains: sodium: 2 mg
    • Store at 20° to 25°C (68° to 77°F)
    • do not use if printed neckband is broken or missing
  • Inactive ingredients

    acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

  • Questions or comments?

    Call 1-800-845-8210.

    ** This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children's Tylenol® Oral Suspension.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    ©2022 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    v-38612

  • PRINCIPAL DISPLAY PANEL

    NDC 51316-781-04

    Children's Pain & Fever

    Acetaminophen

    (160 mg / 5 mL)

    Pain Reliever; Fever Reducer

    Ages 2 to 11 years

    Free of: Alcohol, Aspirin, Ibuprofen & Gluten

    Strawberry Flavor

    4 fl oz (118 mL)

    4 oz bottle label
  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN AND FEVER 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-781
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-781-041 in 1 CARTON03/24/202305/31/2025
    1118 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 DrugM01303/24/202305/31/2025
    Labeler - CVS Pharmacy (062312574)
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