Label: TYLENOL FOR CHILDREN PLUS ADULTS- acetaminophen suspension
- NDC Code(s): 50580-177-08
- 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 April 14, 2021
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
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
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)
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- 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.
- do not give more than directed (see overdose warning)
- shake well before using
- mL = milliliter
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
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?
PRINCIPAL DISPLAY PANEL
Same as Children's TYLENOL
with adult dosing
+ ADULTS FAMILY
Acetaminophen (160 mg per 5 mL)
Pain Reliever-Fever Reducer
Ages 2 Years – Adult
8 fl oz (240 mL)
160 mg per 5 mL
INGREDIENTS AND APPEARANCE
TYLENOL FOR CHILDREN PLUS ADULTS
Product 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 not final part343 07/01/2021 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)