Label: TYLENOL FOR CHILDREN PLUS ADULTS- acetaminophen suspension
- NDC Code(s): 50580-177-08
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 18, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
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 you are 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
- do not give more than directed (see overdose warning)
- shake well before using
- mL = milliliter
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Children 2 years to under 12 years:
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- remove the child protective cap and squeeze the dose into the dosing cup
- repeat dose every 4 hours while symptoms last
- do not take more than 5 times in 24 hours unless directed by a doctor
- do not take for more than 5 days unless directed by a doctor
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Adults and children 12 years and over:
- take 20 mL (2 × 10 mL) every 4 hours while symptoms last. For adult dosing, the dosing cup needs to be filled to 10 mL line twice.
- do not take more than 5 doses (100 mL) in 24 hours unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
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?
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PRINCIPAL DISPLAY PANEL
NDC 50580-177-08
Same as Children's TYLENOL
with adult dosingTYLENOL ®
FOR CHILDREN
+ ADULTS FAMILYAcetaminophen (160 mg per 5 mL)
Oral Suspension
Pain Reliever-Fever ReducerDYE-FREE
Pain+FeverAges 2 Years – Adult
FREE OF:
Dyes
Alcohol
Ibuprofen
Aspirin
Parabens
High Fructose
Corn Syrup8 fl oz (240 mL)
160 mg per 5 mLCherry
Flavor -
INGREDIENTS AND APPEARANCE
TYLENOL FOR CHILDREN PLUS ADULTS
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-177 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) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SORBITOL SOLUTION (UNII: 8KW3E207O2) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-177-08 1 in 1 CARTON 07/01/2021 1 240 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 07/01/2021 Labeler - Johnson & Johnson Consumer Inc. (878046358)