FDA Label for Acetaminophen Extra Strength
View Indications, Usage & Precautions
Acetaminophen Extra Strength 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 Ingredients
Acetaminophen 500 mg
Purpose
Pain Reliever/Fever Reducer
Uses
- temporarily relieves minor aches and pains
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tablets 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptom occur
- redness or swelling is present These could be signs of a serious condition.
Do not use
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
- do not take more than directed
- adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours
- children under 12 years: do not use
Other Information
- TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
- store at 20⁰C-25⁰C (68⁰F-77⁰F)
- for institutional use only
Inactive Ingredients
povidone, sodium starch glycolate, starch stearic acid. May also contain: crospovidone, methylparaben and probylparaben
Package Label.Principal Display Panel
NDC 54868-2457-2
SEE NEW WARNINGS
Non-Aspirin
Extra Strength
PAIN RELIEF
Acetaminophen Tablets
*Compare to active ingredient in Extra Strength Tylenol Tablets
PACKAGE NOT CHILD RESISTANT
500 mg each
Dist. By: Gericare Pharmaceuticals Corp.
1650 63rd Street, Brooklyn, NY 11204Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
* Please review the disclaimer below.