Label: CHILDRENS ACETAMINOPHEN ORAL SUSPENSION- acetaminophen suspension

  • NDC Code(s): 0121-0966-00, 0121-0966-05, 0121-0966-94
  • Packager: PAI Holdings, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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

  • Active ingredient

    (in each 5 mL)
    Acetaminophen 160 mg

  • Purpose

    Acetaminophen
    160 mg.............................Pain reliever/fever reducer

  • Uses temporarily:

    • 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

    Attention: For Single-Dose Cups, the entire dose should be taken.

    Weight (lb)  Age (yr)Dose (mL)*
    under 24               under 2 years         ask a doctor
    24-35                   2-3 years                5 mL
    36-47                   4-5 years                7.5 mL
    48-59                   6-8 years                10 mL
    60-71                   9-10 years              12.5 mL
    72-95                   11 years                 15 mL

    *or as directed by a doctor

  • 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:

       NDC 0121-0966-05: 5 mL unit dose cup, in a tray of ten cups.

       NDC 0121-0966-94: Case contains 30 unit dose cups of 5 mL (0121-0966-05) packaged in 3 trays of 10 unit dose cups each.
       NDC 0121-0966-00: Case contains 100 unit dose cups of 5 mL (0121-0966-05) packaged in 10 trays of 10 unit dose cups each.

  • INACTIVE INGREDIENT

    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.

    MANUFACTURED BY:

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    www.paipharma.com

    R01/22

  • Principal Display Panel

    Delivers 5 mL

    NDC 0121-0966-05

    DYE FREE/GRAPE FLAVOR

    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

    Package Not Child-Resistant

    Pharmaceutical Associates, Inc.

    SEE INSERT

    Children's Acetaminophen Oral Suspension
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ACETAMINOPHEN ORAL SUSPENSION 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0966
    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
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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)  
    Product Characteristics
    Colorwhite (to off-white appearance) Score    
    ShapeSize
    FlavorGRAPE (grape flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0966-943 in 1 CASE03/09/2022
    110 in 1 TRAY
    1NDC:0121-0966-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:0121-0966-0010 in 1 CASE03/09/2022
    210 in 1 TRAY
    2NDC:0121-0966-055 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 DrugM01303/09/2022
    Labeler - PAI Holdings, LLC (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma097630693label(0121-0966) , manufacture(0121-0966)