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Drug Facts
Acetaminophen 325mg Tablet
FDA Label NDC 10135-828
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 325mg (NDC 10135-828). 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(in each tablet), purpose, uses, warnings, do not use, ask a doctor, ask a doctor or pharmacist before use, 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 325 mg
Purpose
Pain Reliever/Fever Reducer
Uses
To reduce fever and for the temporary relief of minor aches and pains due to:
- Headache
- Backache
- The common cold
- Premenstrual and menstrual cramps
- Temporarily reduces fever
- Muscular ache
- Minor pain of arthritis
- Toothache
Warnings
Liver warning:this product contains acetaminophen.
Severe liver damage may occur if
- adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
- child takes more than 5 doeses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 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 in adults and children.
- Pain gets worse or lasts more than 5 days in children under 12 years.
- 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
Adults and Children 12 years and over:
- Take 2 tablets every 4 to 6 hours while symptoms last.
- Do not take more than 12 tablets in 24 hours
- Take 1 tablet every 4 to 6 hours while symptoms last.
- Do not take more than 5 tablets in 24 hours.
Children 6-11 years:
Children under 6years:
Do not use this adult regular strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
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
NDC 10135-0828-01
Acetaminophen
325 mg
100 TABLETS
828-01 (828 01)
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