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Drug Facts
Acetaminophen Tablet
FDA Label NDC 10135-829
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marlex Pharmaceuticals Inc for the product Acetaminophen (NDC 10135-829). 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 other, active ingredient, purpose, uses, warnings, do not use, ask a doctor, ask a doctor or pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
(in each tablet)
Acetaminophen USP 500 mg
Purpose
Pain Reliever/Fever Reducer
Uses
Temporary relieves minor aches and pains due to:
- The common cold • Headache
- Backache • Minor pain of arthritis
- Toothache • Muscular aches
- Premenstrual and menstrual cramps
* Temporarily reduces fever
Warnings
Liver warning:this product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- 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.
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 overdosewarning)
Adults and Children 12 years and over:
- Take 2 tablets every 6 hours while symptoms last.
- Do not take more than 6 tablets in 24 hours, unless directed by a doctor.
- Do not use for more than 10 days unless directed by a doctor.
- ask a doctor.
Children under 12 years:
Other Information
- Store between 20-25 ˚C (68-77 ˚F).
Inactive Ingredients
Pregelatinized Starch, Povidone K 30,Sodium starch Glycolate, Stearic Acid.
Manufactured for/ Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Rev. 01/26 AA
Principal Display Panel
829-01 (829 01)
ACETAMINOPHEN
500 MG
* Please review the disclaimer below.
