Label: CHILDRENS TYLENOL- acetaminophen powder
- NDC Code(s): 50580-555-04, 50580-555-05
- Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 8, 2021
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each powder)
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
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)
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
- 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
INGREDIENTS AND APPEARANCE
Product 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 NOT FINAL part343 07/15/2019 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)