Acetaminophen Extra Strength by Physicians Total Care, Inc.
Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-3832
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
*Compared to the active ingredient in Extra Strength Tylenol®
(in each tablet)
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
For the temporary relief of minor aches and pains due to:
- Muscular aches
- Minor pain of arthritis
- The common cold
- Premenstrual and menstrual cramps
Temporarily reduces fever.
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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 you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Stop use and ask a doctor if
- Pain gets worse or lasts more than 10 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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
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 for adults as well as for children even if you do not notice any signs or symptoms.
Do not take more than directed.
Adults and children 12 years and over:
- Take 2 caplets every 4 to 6 hours while symptoms last
- Do not take more than 8 caplets in 24 hours
- Do not take for more than 10 days unless directed by a doctor
Children under 12 years:
- Do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
- Store at room temperature 15°-30°C (59°-86°F)
- Use by expiration date on package
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®.
104 Hippocrates Way,
Glasgow, KY 42141
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
Keep out of reach of children.
|Labeler - Physicians Total Care, Inc. (194123980)|
|Physicians Total Care, Inc.||194123980||relabel(54868-3832)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.