Label: CHILDRENS PAIN AND FEVER- acetaminophen suspension

  • NDC Code(s): 76281-526-23, 76281-526-24
  • Packager: AptaPharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 2, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    (in each 5 mL = 1 teaspoonful)
    Acetaminophen 160 mg

  • PURPOSE

    Purpose
    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses temporarily ■ reduces fever
    ■ relieves minor aches and pains due to:
    ■ the common cold ■ flu ■ headache ■ sore throat
    ■ toothache

  • WARNINGS

    Warnings
    Liver warning
    This product contains acetaminophen. Severe liver
    damage may occur nyour 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 ever, headache, rash.
    nausea or vomiting, consult a doctor promptly.

  • DO NOT USE

    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 DOCTOR

    Ask a doctor before use if your child has liver disease.

  • ASK DOCTOR/PHARMACIST

    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

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    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.

  • DOSAGE & ADMINISTRATION

    Directions (Children's Pain & Fever)
    ■ 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.

    Directions (Infants' Pain Relief)
    ■ 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)*
     Under 24 Under 2 years Ask a doctor
     24-35 2-3 years 5 mL

    *or as directed by a doctor

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

  • OTHER SAFETY INFORMATION

    Other information
    each 5 mL (1 tsp) contains; sodium 3 mg
    ■ store between 20-25ºC (68-77ºF)
    ■ do not refrigerate
    ■ Keep carton for full directions for use.

  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous citric acid,
    butylparaben. D&C Red #33. FD&C Blue #1. flavor,
    glycerin, high fructose corn syrup, microcrystalline
    cellulose and carboxymethylcellulose sodium.
    propylene glycol, purified water, sodium benzoate,
    sorbitol solution, sucralose, xanthan gum.

  • QUESTIONS

    Questions? Call weekdays from 9:30 AM to 4:30

    PM EST at 1-877-798-5944

  • Product Label

    AP SAFE®​                     NDC 76821-526-24

    COMPARE TO THE

    ACTIVE INGREDIENT IN

    CHILDREN'S TYLENOL®

    ORAL SUSPENSION*

    Children's

    Pain

    & Fever

    Acetaminophen

    Oral Suspension

    Pain reliever/Fever Reducer

    • Alcohol-Free
    • Ibuprofen Free
    • Aspirin Free
    • For Ages 2 to 11

    4 FL OZ (118 mL)

    160 mg per 5 mL

    Grape Flavor

    DO NOT USE IF PRINTED NECK BAND IS
    BROKEN OR MISSING

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

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

    AP-BX-06

    Carton

    526-24 4OZ Box

    Bottle

    526-24 4OZ Btl

    Carton

    526-23 03 2 Oz Box

    Bottle

    526-23 03 2 Oz Botl

    res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN AND FEVER 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-526
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-526-241 in 1 CARTON09/30/2020
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:76281-526-231 in 1 CARTON01/30/2024
    259 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/21/2013
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-526)