Label: CHILDRENS TYLENOL- acetaminophen suspension

  • NDC Code(s): 50580-296-04, 50580-296-50, 50580-296-51
  • Packager: McNeil Consumer Healthcare Div McNeil-PPC, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each 5 mL = 1 teaspoonful)

    Acetaminophen 160 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    temporarily:

    • reduces fever
    • relieves minor aches and pains due to:
      • the common cold
      • flu
      • headache
      • sore throat
      • toothache
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  • 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 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 occur
    • redness or swelling is present

    These could be signs of a serious condition.

    Keep out of reach of children.

    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.

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  • Directions

    • this product does not contain directions or complete warnings for adult use.
    • do not give more than directed (see overdose warning)
    • shake well before using
    • mL = milliliter; tsp = teaspoonful
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • remove the child protective cap and squeeze your child's dose into the dosing cup
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    Weight (lb) Age (yr) Dose (mL or tsp) *
    *
    or as directed by a doctor
    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 (1½ tsp)
    48-59 6-8 years 10 mL (2 tsp)
    60-71 9-10 years 12.5 mL (2½ tsp)
    72-95 11 years 15 mL (3 tsp)

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

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  • Other information

    • each 5 mL (1 tsp) contains: sodium 2 mg
    • store between 20-25°C (68-77°F)
    • do not use if carton is opened or if carton tape or bottle wrap imprinted "SAFETY SEAL®" is broken or missing
    • see bottom panel for lot number and expiration date
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  • Inactive ingredients

    anhydrous citric acid, butylparaben, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

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  • Questions or comments?

    call 1-877-895-3665

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  • PRINCIPAL DISPLAY PANEL

    See New Directions

    NDC 50580-296-50

    Children's
    TYLENOL
    ®

    Acetaminophen
    Oral Suspension
    Pain Reliever-Fever Reducer

    PAIN & FEVER
    Ages 2-11

    Ibuprofen Free
    Alcohol Free
    Aspirin Free

    Grape
    Splash

    FLAVOR

    4 fl oz (120 ml)
    160 mg per 5 ml

    Principal Display Panel
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS TYLENOL 
    acetaminophen suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50580-296
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (acetaminophen) Acetaminophen 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid  
    butylparaben  
    D&C red NO. 33  
    FD&C blue NO. 1  
    glycerin  
    high fructose corn syrup  
    cellulose, microcrystalline  
    carboxymethylcellulose sodium  
    propylene glycol  
    water  
    sodium benzoate  
    sorbitol  
    sucralose  
    xanthan gum  
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor GRAPE (Grape Splash) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-296-04 1 in 1 CARTON
    1 120 mL in 1 BOTTLE
    2 NDC:50580-296-51 2 in 1 PACKAGE
    2 NDC:50580-296-50 1 in 1 CARTON
    2 120 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 07/01/2004
    Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)
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