Label: CHILDRENS TYLENOL- acetaminophen powder
- NDC Code(s): 50580-555-04, 50580-555-05
- Packager: Kenvue Brands LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 7, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each powder)
- 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
When using this product do not exceed recommended dose (see 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)
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- tear packet and pour powder on your child's tongue
- 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 powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-555 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SUCRALOSE (UNII: 96K6UQ3ZD4) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color white (off white) Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-555-04 30 in 1 CARTON 07/15/2019 1 1 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:50580-555-05 18 in 1 CARTON 07/15/2019 2 1 in 1 PACKET; 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 07/15/2019 Labeler - Kenvue Brands LLC (118772437)