Label: CHILDRENS PAIN AND FEVER- acetaminophen liquid

  • 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 October 28, 2019

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

  • Active ingredient

    Drug Facts

    Active ingredient
    (in each 5 mL = 1 teaspoonful)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Keep out of reach of children

    Keep out of reach of children.

  • Uses

    temporarily

    reduces fever
    relieves 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

    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 other 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 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
    • redness or swelling is present  These could be signs of a serious condition.
  • Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. 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 for children even if you do not notice any signs or symptoms.

  • Directions

    this product does not contain directions or complete warnings for adult use
    shake well before using
    mL = milliliter;   tsp = teaspoonful
    find the right dose on the chart below. If possible, use weight to dose, otherwise, use age.
    if needed, repeat dose every 4 hours while symptoms last
    do not give more than 5 times in 24 hours
    do not give for more than 5 days unless directed by a doctor.

    Weight (lb)                                      Age (yr)                                        Dose (mL or  tsp)*

    under 24                                     under 2 years                                      ask a doctor

    24-35                                              2 - 3 years                                      5 mL (1 tsp)

    36-47                                              4 - 5 years                                      7.5 mL (1 1/2 tsp0

    48-59                                              6 - 8 years                                      10 mL (2 tsp)

    60-71                                             9 - 10 years                                     12.5. mL (2 1/2 TSP)

    72-95                                                  11 years                                     15 mL (3 tsp)

    *or as directed by a doctor

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.                   

  • Other information

    • each 5 mL (1 tsp) contains: sodium 3 mg
    • store between 20-25° C (68-77° F)
    • do not refrigerate
  • Inactive ingredients

    anhydrous citric acid, butylparaben, FD and C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethycellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

  • Questions?

    Call weekdays from 9:30 AM to 4:30 PM EST at

    1-877-798-5944

  • Product Label

    SOUND BODY™

    COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S TYLENOL® ORAL SUSPENSION

    Children's

    Pain and Fever

    Acetaminophen

    Oral Suspension
         Alcohol Free
        Ibuprofen Free
        Aspirin Free

    For Ages 2 to 11

    CHERRY FLAVORED

    4 FL OZ (118 mL)
    160 mg per 5 mL

    DO NOT USE IF PRINTED NECKBAND IA BROKEN OR MISSING

    *This product is not manufactures or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral Suspension.

    Manufactured by:
    AptaPharma Inc.,
    1533 Union Ave
    Pennsauken, NJ 08110

    V#5002632    ITEM#302

    BX-003 Rev 1

    AptaPharma ChildPainFever Label

    AptaPharma ChildPainFever1 Label

    res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN AND FEVER 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-302
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-302-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/21/2013
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-302)