Label: CHILDRENS PAIN AND FEVER- acetaminophen liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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

  • Drug FactsActive ingredient(in each 5 mL = 1 teaspoonful)

    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 warning: This product contains acetaminophen.
    Severe liver damage may occur if your child takes:

    • more than 5 doses in 24 hours, which is the maxium daily amount
    • with other drugs containing acteaminophen

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stopuse and seek medical help right away.

    Sore throat warning: If a sore throat is severe, persiss 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 to any of the inactive ingredients in this product
  • Ask a doctor 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 warnings)

  • 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 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 = millititer; tsp = teaspoonful
    • find right dose on chart below. If possible, use weight to dose, otherwise, use age.
    • if needed, repeat dose every 4 hours while symptoms last
    • 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 tsp)

    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

    * or as directed by a doctor

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

  • Other information

    • eash 5mL (1 tsp) contains sodium 3mg
    • store between 20-25
  • Inactive ingrediants

    anhydrous citric acid, butylparaben, D&C Red # 33, FD&C (red), flavor, glycerin, flavor, high frucotose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum   

  • Questions

    Call weekays from 9:30 AM to 4:30 PM

  • Children's Pain & Fever product label

    DISCOUNT
    drug mart
    FOOD FAIR

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

    Fever Reducer / Pain Reliever

    Children's Pain & Fever

    Acetaminophen Oral Suspension

    • Alcohol-Free
    • Ibuprofen Free
    • Aspirin Free

    For Ages 2 to 11

    GRAPE FLAVOR

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

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

    BX-053

    SATISFACTION GUARANTEED

    IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STOORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

    AptaPharmDD ChildPainFever 526

    AptaPharmDD ChildPainFever 526 1

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    AptaPharmDD ChildPainFever 526

    AptaPharmDD ChildPainFever 526 1

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN AND FEVER 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-526
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MICROCRYSTALLINE CELLULOSE (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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-526-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/04/2016
    Labeler - Discount Drug Mart (047741335)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(53943-526)