Active Ingredient
Acetaminophen 500 mg
Extra Strength Acetaminophen Tablet
FDA Label NDC 57896-222
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceutical Corp for the product Extra Strength Acetaminophen (NDC 57896-222). 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, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain Reliever/Fever Reducer
Uses
- temporarily relieves minor aches and pains
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. The
maximum daily dose of this product is 6 caplets in 24 hours.
Severe liver damage may occur if you take:
- more than 8 caplets (4,000 mg of acetaminophen) in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
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
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
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 caplets
every 4-6 hours, as needed. Do not take more than 6
caplets in 24 hours, unless directed by a doctor. - 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)
Inactive Ingredients
corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
* Please review the disclaimer below.
