FDA Label for Acetaminophen
View Indications, Usage & Precautions
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Chewable Tablet)
Acetaminophen 80 mg
Purposes
Pain Reliever/Fever Reducer
Uses
Temporarily relieves minor aches and pain due to:
■ The common cold ■ Flu ■ Headache ■ Sore throat
■ Toothache
Temporarily reduces fever.
Warnings
Liver warning: 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.
Otc - Do Not Use
Do not use ■ with any other other drug containing acetaminophen (prescription or non prescription). 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.
Otc - Stop Use
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 reach of children.
Overdosage
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
■ This products does not contain directions or complete warnings for adult use.
■ Find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
■ Chew before swallowing
■ If needed, repeat dose every 4 hours while symptoms lasts
■ Do not give more than 5 times in 24 hours
■ Do not give for more than 5 days unless directed by a doctor.
| Weight | Age | Tablets |
| Under 24 lbs | Under 2 years | Ask a doctor |
| 24-35 lbs | 2-3 years | 2 tablets |
| 36-47 lbs | 4-5 years | 3 tablets |
| 48-59 lbs | 6-8 years | 4 tablets |
| 60-71 lbs | 9-10 years | 5 tablets |
| 72-95 lbs | 11 years | 6 tablets |
Other Information
- Phenylketonurics: Contain Phenylalanine 14 mg per tablet
- Do not use if imprinted safety seal under cap is broken or missing
- Store at room temperature in a dry place
Inactive Ingredients
Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.
Questions?
Adverse Drug Event Call: (800) 616-2471
Principal Display Panel
NDC 54868-5625-0
*Compare to the active ingredient in Children's Chewable Tylenol®
Children's Chewable
AGES 2-6
Acetaminophen Chewable Tablets
30 Tablets, 80 mg EACH
Fever reducer/ Pain reliever
ASPIRIN FREE ● IBUPROFEN FREE
| See New Warnings Information |
* Please review the disclaimer below.