Active Ingredient
(in each tablet)
Acetaminophen 325 mg
Acetaminophen
FDA Label NDC 54868-0548
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Acetaminophen (NDC 54868-0548). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purposes, uses, warnings, otc - keep out of reach of children, overdosage, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain Reliever/Fever Reducer
Uses
for the temporary relief of minor aches and pains due to:
- Headache
- Muscular aches
- Backache
- Minor pain of arthritis
- The common cold
- Toothache
- Premenstrual and menstrual cramps
Temporarily reduces fever.
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- 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 you are allergic to acetaminophen or any of the inactive ingredients in this product
- Pain gets worse or lasts more than 10 days in adults and children
- Pain gets worse or lasts more than 5 days in children under 12 years
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Redness or swelling is present
Do not use
Ask a doctor before use if the user has liver disease.
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
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 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.
Directions
Do not take more than directed
| Age | Dose |
| Adults and Children 12 years and over |
|
| Children 6-11 years |
|
| Children under 6 years | Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage. |
Other Information
- Store at room temperature 15°-30°C (59°-86°F)
- Use by expiration date on package.
Inactive Ingredietns
Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid
Questions? To report a Serious Adverse Event contact 1-877-835-5472.
*This product is not manufactured or distributed by McNeil Consumer Products Co., owners of the registered trademark Tylenol®.
Distributed by:
Amneal Pharmaceuticals
104 Hippocrates Way,
Glasgow, KY 42141
Rev. 11/2009
Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK 74146
Package Label.Principal Display Panel
Acetaminophen Tablets
325 mg
| Bottles of 50 | NDC 54868-0548-2 |
| Bottles of 100 | NDC 54868-0548-4 |
| Bottles of 1000 | NDC 54868-0548-3 |
* Please review the disclaimer below.
