Active Ingredient (In Each Tablet)
Acetaminophen 500 mg
Acetaminophen Tablet
FDA Label NDC 82568-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aarna Usa Inc. for the product Acetaminophen (NDC 82568-0002). 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 (in each tablet), purpose, uses, warnings, directions - do not take more than directed (see overdose warning), other information, inactive ingredients:, questions or comments?, 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
To reduce fever and 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 you take
- more than 4,000 mg of acetaminophen in 24 hours
- 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if the user has ever had an allergic reaction to this product or any of its ingredients.
- 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.
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 the user has
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.
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 (See Overdose Warning)
adults & children
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children under 12 years |
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Other Information
store at 20° to 25°C (68° to 77°F)
Inactive Ingredients:
Gelatinized starch, magnesium stearate, povidone
Questions Or Comments?
Call toll-free 1-877-225-6999
Manufactured for
AARNA USA INC.
Leland, NC 28451
* This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.
Package Label.Principal Display Panel
* Please review the disclaimer below.
