Label: INFANTS TYLENOL- acetaminophen suspension
- NDC Code(s): 50580-433-01, 50580-433-02
- 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 December 7, 2017
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 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)
- 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
Dosing Chart Weight (lb) Age (yr) Dose (mL)*
- or as directed by a doctor
under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL
- Other information
- Inactive ingredients
- Questions or comments?
PRINCIPAL DISPLAY PANEL
Acetaminophen 160 mg per 5 mL Oral Suspension
Pain Reliever-Fever Reducer
Pain + Fever
See side panel for more information
Use Only Enclosed Syringe
1 fl oz (30 mL)
160 mg per 5 mL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-433 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 (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) xanthan gum (UNII: TTV12P4NEE) Product Characteristics Color PURPLE (reddish-purple) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-433-01 1 in 1 CARTON 08/07/2017 1 30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:50580-433-02 1 in 1 CARTON 09/29/2017 2 60 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 08/07/2017 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)