Label: CHILDRENS ACETAMINOPHEN- acetaminophen suspension

  • NDC Code(s): 0121-1781-00, 0121-1781-05
  • Packager: Pharmaceutical Associates, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 28, 2022

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

  • Drug Facts

  • Active ingredient                                                                                  (in each 5 mL)  

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily:

    • reduces fever
    • relieves minor aches and pain due to:
      • the common cold
      • flu
      • headache
      • sore throat
      • toothache

  • Warnings

    Liver warning: This product contains 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 REACH OF CHILDREN

    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 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
    *
    or as directed by a doctor
    Weight (lbs)Age (yr)Dose (mL) *
    Under 24Under 2Ask 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 

  • Other information

    • each 5 mL contains: sodium 2 mg
    • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
    • protect from freezing
    • a red, berry flavored suspension supplied in the following oral dosage form:

    NDC 0121-1781-05:  5 mL unit dose cup, in a tray of ten cups

  • Inactive ingredients

    Acesulfame K, butylparaben, citric acid, FD&C Red No. 40, 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

    MANUFACTURED BY

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    www.paipharma.com

    R09/20

  • PRINCIPAL DISPLAY PANEL - 5 mL Cup

    Delivers 5 mL

    NDC 0121-1781-05

    CHILDREN'S ACETAMINOPHEN  ORAL SUSPENSION

    160 mg per 5 mL

    Ibuprofen Free/ Alcohol Free / Aspirin Free

    SHAKE WELL BEFORE USING

    Package Not Child-Resistant

    PHARMACEUTICAL ASSOCIATES, INC.

    GREENVILLE, SC 29605

    SEE INSERT

    5 mL Unit Dose Cup Label

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ACETAMINOPHEN 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1781
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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
    ColorredScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1781-0010 in 1 CASE09/17/2007
    110 in 1 TRAY
    1NDC:0121-1781-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/17/2007
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-1781)