The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
**This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children’s Tylenol® Oral
MANUFACTURED BYPharmaceutical Associates, Inc.Greenville, SC 29605www.paipharma.comR06/21
Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
Pain reliever/fever reducer
- Temporarily:reduces feverrelieves minor aches and pains due to:
- The common coldfluheadachesore throattoothache
Liver warningsThis 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
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
Otc - Ask Doctor
Ask a doctor before use if your child has liver diseaseAsk a doctor or pharmacist before use if your child is taking the blood thinning drug warfarinWhen using this product, do not exceed the 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.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
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 children even if you do not notice any sign or symptoms.
- This product does not contain directions or complete warnings for adult usedo not take more than directed (see overdose warning)shake well before usingmL = milliliterfind right dose on chart below. If possible, use weight to dose; otherwise, use age.repeat dose every 4 hours while symptoms lastdo not give more than 5 times in 24 hoursWeight (lb)Age (yr)Dose (mL)*Under 24Under 2 yearsask a doctor24-352-3 years5 mL36-474-5 years7.5 mL48-596-8 years10 mL60-719-10 years12.5 mL72-9511 years15 mL*or as directed by a doctor
- Each 5 mL contains: sodium: 2 mgStore at 20° to 25°C (68° to 77°F)grape flavored suspension supplied in the following oral dosage forms:NDC 0121-0946-05: 5 mL unit dose cup, in a tray of ten cups.
Acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.
* Please review the disclaimer below.