FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
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.
Overdose warning: 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.
Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
Pain reliever/fever reducer
- 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
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
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
Otc - When Using
When using this product do not exceed recommended dose (see
Stop Use And Ask A Doctor If:
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see
- shake well before using
- mL = milliliter
- 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)
|under 24||under 2 years||Ask a doctor|
|24-35||2-3 years||5 mL |
|36-47||4-5 years||7.5 mL |
|48-59||6-8 years||10 mL |
|60-71||9-10 years||12.5 mL |
|72-95||11 years||15 mL |
*or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- each 5 mL contains: sodium: 2 mg
- Store at 20° to 25°C (68° to 77°F)
- do not use if carton tape or printed neckband is broken or missing
acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.
** This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children's Tylenol
® Oral Suspension.
Pharmaceutical Associates Inc.
Greenville, SC 29605
Principal Display Panel
Ages 2-11 Years
(160 mg per 5 mL)
Pain Reliever+Fever Reducer
Made in the USA
Ibuprofen Free • Alcohol Free •Aspirin Free
4 fl oz (118 mL)
* Please review the disclaimer below.