Label: CHILDRENS TYLENOL- acetaminophen tablet, chewable
- NDC Code(s): 50580-522-24
- Packager: Kenvue Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 1, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
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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
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
- Overdose warning
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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)
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- find 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
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDRENS TYLENOL
acetaminophen tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-522 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CELLULOSE ACETATE (UNII: 3J2P07GVB6) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color purple Score 2 pieces Shape ROUND Size 16mm Flavor GRAPE Imprint Code TY;160;HALF;HALF Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-522-24 1 in 1 CARTON 02/27/2017 1 24 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 02/27/2017 Labeler - Kenvue Brands LLC (118772437)