Label: CHILDRENS ACETAMINOPHEN ORAL SUSPENSION- acetaminophen suspension

  • NDC Code(s): 60687-762-17, 60687-762-40, 60687-762-46
  • Packager: American Health Packaging
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2024

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

  • Active ingredient

    (in each 5 mL)
    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Usestemporarily:

    • reduces fever
    • 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 non-prescription). 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 DOCTOR

    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

    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

    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 children even if you do not notice any sign or symptoms.

  • Directions

    • this product does not contain directions or complete warnings for adult use.
    • do not take 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
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    *
    or as directed by a doctor

    Weight (lb)

    Age (yr)

    Dose (mL)*

    under 24

    under 2 years

    ask a doctor

    24-35

    2-3 years

    5 mL (1 unit dose cup)

    36-47

    4-5 years

    7.5 mL (1.5 unit dose cups)

    48-59

    6-8 years

    10 mL (2 unit dose cups)

    60-71

    9-10 years

    12.5 mL (2.5 unit dose cups)

    72-95

    11 years

    15 mL (3 unit dose cups)

  • Other information

    • each 5 mL contains: sodium: 2 mg
    • Store at 20° to 25°C (68° to 77°F)

      grape flavored suspension supplied in the following oral dosage form:
      5 mL unit dose cups: 100 cups (10 x 10) NDC 60687-762-17

  • Inactive Ingredients:

    acesulfame K, butylparaben, citric acid, 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.

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF SEAL IS BROKEN.

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    T0966C050423
    R04/23

  • Principal Display Panel – Tray – 160 mg/5 mL

    160 mg/5 mL Children’s Acetaminophen Oral Suspension Tray Label

    Case NDC 60687-762-17/Cup NDC 60687-762-40

    Children’s Acetaminophen
    Oral Suspension
    160 mg per 5 mL

    DYE FREE/GRAPE FLAVOR

    Ibuprofen Free/Alcohol Free/Aspirin Free

    Pain Reliever-Fever Reducer

    SHAKE WELL BEFORE USING

    USUAL DOSAGE: See attached Drug Facts

    Store at 20° to 25°C (68° to 77°F)

    For Institutional Use Only.

    T0966C050423            R04/23

  • Principal Display Panel – Cup – 160 mg/5 mL

    160 mg/5 mL Children’s Acetaminophen Oral Suspension Cup

    NDC 60687- 762-40

    CHILDREN’S
    ACETAMINOPHEN
    ORAL SUSPENSION

    Pain Reliever-Fever Reducer

    160 mg per 5 mL

    DYE FREE/GRAPE FLAVOR
    Ibuprofen Free/Alcohol Free/Aspirin Free

    Delivers 5 mL

    SHAKE WELL BEFORE USING

    See package Drug Facts inert for full
    prescribing information and storage.

    For Institutional Use Only.

    American Health Packaging
    Columbus, OH 43217

    F0966C50423

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ACETAMINOPHEN ORAL SUSPENSION 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-762
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorwhite (to off-white appearance) Score    
    ShapeSize
    FlavorGRAPE (grape flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60687-762-1710 in 1 CASE09/06/2023
    1NDC:60687-762-4610 in 1 TRAY
    1NDC:60687-762-405 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/06/2023
    Labeler - American Health Packaging (929561009)