Label: CHILDRENS TYLENOL- acetaminophen kit
- NDC Code(s): 50580-460-01, 50580-522-24, 50580-612-01
- Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 21, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Childrens Tylenol
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
-
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)
-
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?
- Childrens Tylenol
- Active ingredient (in each 5 mL)
- Purpose
- Uses
-
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)
-
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
- 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 as directed by a doctor
under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- Other information
- Inactive ingredients
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL
NDC 50580-460-01
Children's
TYLENOL ®Acetaminophen (160 mg per 5 mL)
Oral SuspensionPain Reliever-Fever Reducer
Pain+Fever
Ages 2-11 YearsIbuprofen Free
Alcohol Free
Aspirin FreeNo Parabens
4 fl oz (120 mL)
160 mg per 5 mL
Grape
FlavorBE READY
AT HOME
OR
ON-THE-GOUse products only as directed
NDC 50580-460-01
Children's
TYLENOL ®Acetaminophen
Pain Reliever
Fever ReducerPain+Fever
Ages 2-11
ChewablesChew or crush tablets completely
before swallowing
Ibuprofen FreeAspirin Free
160 mg
Per Tablet24
Chewable
Tablets
Actual Size
160 mg each
Grape Flavor -
INGREDIENTS AND APPEARANCE
CHILDRENS TYLENOL
acetaminophen kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-460 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-460-01 1 in 1 PACKAGE 05/07/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 24 Part 2 1 BOTTLE 120 mL Part 1 of 2 CHILDRENS TYLENOL
acetaminophen tablet, chewableProduct Information 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 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) CELLULOSE ACETATE (UNII: 3J2P07GVB6) CROSPOVIDONE (UNII: 2S7830E561) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) 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 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 not final part343 02/27/2017 Part 2 of 2 CHILDRENS TYLENOL
acetaminophen suspensionProduct Information Item Code (Source) NDC:50580-612 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL SOLUTION (UNII: 8KW3E207O2) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color purple Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-612-01 1 in 1 CARTON 1 120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/07/2018 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)