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
  • Marketing Status: OTC monograph not 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 August 1, 2023

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  • Active ingredient

    (in each 5 mL)
    Acetaminophen160 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 hasliver disease.

    Ask a doctor or pharmacist before use if your childis 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 CASE08/01/2023
    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 not finalpart34308/01/2023
    Labeler - American Health Packaging (929561009)
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