Label: CHILDRENS ACETAMINOPHEN suspension

  • NDC Code(s): 0121-0946-00, 0121-0946-05, 0121-0946-30
  • Packager: Pharmaceutical Associates, Inc.
  • 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 May 26, 2022

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

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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 warnings

    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 the 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 the 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
    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

  • 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 forms:

    NDC 0121-0946-05: 5 mL unit dose cup, in a tray of ten cups.

  • 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.

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

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    www.paipharma.com

    R06/21

  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

    Delivers 5 mL
    NDC 0121-0946-05

    Children's Acetaminophen Oral Suspension

    160 mg per 5 mL

    DYE FREE/GRAPE FLAVOR

    Ibuprofen Free/Alcohol Free/Aspirin Free

    Package Not Child-Resistant

    Rx ONLY

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    A0946050621

    PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ACETAMINOPHEN 
    childrens acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0946
    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)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorwhite (to off-white) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0946-303 in 1 CASE09/07/2021
    110 in 1 TRAY
    1NDC:0121-0946-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:0121-0946-0010 in 1 CASE09/07/2021
    210 in 1 TRAY
    2NDC:0121-0946-055 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 not finalpart34309/07/2021
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-0946) , label(0121-0946)
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