Label: INFANTS TYLENOL- acetaminophen suspension
- NDC Code(s): 50580-599-01, 50580-599-02, 50580-599-03
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 31, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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)
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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
- find right dose on chart. If possible, use weight to dose; otherwise, use age.
- push air out of syringe. Insert syringe tip into bottle opening
- flip bottle upside down. Pull yellow part of syringe to correct dose
- dispense liquid slowly into child's mouth, toward inner cheek
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- replace cap tightly to maintain child resistance
- Other information
- Inactive ingredients
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL
NDC 50580-599-03
Infants'
TYLENOL ®
For ChildrenAcetaminophen 160 mg per 5 mL Oral Suspension
Pain Reliever-Fever ReducerDYE-FREE
Pain+Fever
Infants
Free Of:
- Dyes
- Alcohol
- Ibuprofen
- Aspirin
- Parabens
- High Fructose
Corn Syrup
SimpleMeasure ®
Specially designed for younger childrenUse Only Enclosed Syringe
*Same as Children's TYLENOL1 fl oz ( 30 mL)
160 mg per 5 mL*Cherry
Flavor -
INGREDIENTS AND APPEARANCE
INFANTS TYLENOL
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-599 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 XANTHAN GUM (UNII: TTV12P4NEE) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SORBITOL SOLUTION (UNII: 8KW3E207O2) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Product Characteristics Color white (Dye Free) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-599-01 1 in 1 CARTON 06/26/2017 1 60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:50580-599-03 1 in 1 CARTON 04/20/2020 2 30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 3 NDC:50580-599-02 2 in 1 CARTON 03/24/2022 3 30 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 Drug M013 06/26/2017 Labeler - Johnson & Johnson Consumer Inc. (878046358)