Label: CHILDRENS PAIN AND FEVER- acetaminophen suspension

  • NDC Code(s): 51316-098-19, 51316-098-36
  • Packager: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 18, 2024

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  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • toothache
      • sore throat
      • flu
      • the common cold
    • 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.

    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.

    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
    • any new symptoms appear
    • redness or swelling is present

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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
    • shake well before using
    • mL = milliliter
    • only use the dose cup provided
    • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • 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 2Ask a doctor
    24-352-35 mL
    36-474-57.5 mL
    48-596-810 mL
    60-719-1012.5 mL
    72-951115 mL

    *or as directed by a doctor

  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    anhydrous citric acid, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    ♥CVS
    Health®

    Compare to the active
    ingredient in Children’s
    Tylenol® Oral Suspension†

    Oral Suspension

    Children’s
    Pain &
    Fever
    ACETAMINOPHEN
    160 mg / 5 mL

    Pain reliever; Fever reducer

    Ages 2 to 11 years

    • Free of alcohol
    • Aspirin Free
    • Ibuprofen Free
    • Paraben Free

    DYE
    FREE

    Grape Flavored
    Dosage Cup Included

    Package
    Contains
    One Bottle

    8 FL OZ (237 mL)

    DIRECTIONS:

    Step 1.
    Shake well 
    before using

    Step 2.
    Remove child-
    protective cap

    Step 3.
    Pour your 
    child’s dose 
    into the 
    dosing cup

    IMPORTANT:
    Please see dosing chart or ask
    a doctor for your child’s correct dose.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    †This product is not manufactured or distributed by Kenvue
    Inc., owner of the registered trademark Children’s Tylenol®
    Oral Suspension.

    50844 ORG022409819

    Distributed by:
    CVS Pharmacy, Inc.
    One CVS Drive
    Woonsocket, RI 02895
    © 2024 CVS/pharmacy
    CVS.com®
    1-800-SHOP CVS
    V-11112

    100% money back
    guaranteed.
    CVS.com/returnpolicy

    CVS 44-098

    CVS 44-098

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN AND FEVER 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-098
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-098-191 in 1 CARTON04/05/2024
    1237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:51316-098-361 in 1 CARTON04/05/2024
    2118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/05/2024
    Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(51316-098) , pack(51316-098)
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