Label: CHILDRENS TYLENOL- acetaminophen suspension
- NDC Code(s): 50580-296-04, 50580-296-50, 50580-296-51
- Packager: McNeil Consumer Healthcare Div McNeil-PPC, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL = 1 teaspoonful)
Acetaminophen 160 mgClose
Pain reliever/fever reducerClose
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- sore throat
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
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.
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- 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; tsp = teaspoonful
- 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 tsp) *
- or as directed by a doctor
under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL (1 tsp) 36-47 4-5 years 7.5 mL (1½ tsp) 48-59 6-8 years 10 mL (2 tsp) 60-71 9-10 years 12.5 mL (2½ tsp) 72-95 11 years 15 mL (3 tsp)
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.Close
- Other information
- each 5 mL (1 tsp) contains: sodium 2 mg
- store between 20-25°C (68-77°F)
- do not use if carton is opened or if carton tape or bottle wrap imprinted "SAFETY SEAL®" is broken or missing
- see bottom panel for lot number and expiration date
- Inactive ingredients
anhydrous citric acid, butylparaben, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gumClose
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
See New Directions
Pain Reliever-Fever Reducer
PAIN & FEVER
4 fl oz (120 ml)
160 mg per 5 ml
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-296 Route of Administration ORAL DEA Schedule 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) butylparaben (UNII: 3QPI1U3FV8) D&C red NO. 33 (UNII: 9DBA0SBB0L) FD&C blue NO. 1 (UNII: H3R47K3TBD) glycerin (UNII: PDC6A3C0OX) high fructose corn syrup (UNII: XY6UN3QB6S) cellulose, microcrystalline (UNII: OP1R32D61U) carboxymethylcellulose sodium (UNII: K679OBS311) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) xanthan gum (UNII: TTV12P4NEE) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE (Grape Splash) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-296-04 1 in 1 CARTON 1 120 mL in 1 BOTTLE 2 NDC:50580-296-51 2 in 1 PACKAGE 2 NDC:50580-296-50 1 in 1 CARTON 2 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 07/01/2004 Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)