Active Ingredient (In Each Tablet)
Acetaminophen 500 mg
Duralgina Extra Strength Tablet
FDA Label NDC 53145-830
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors, Inc. for the product Duralgina Extra Strength (NDC 53145-830). 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, liver warning, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, stop use and ask a doctor if, 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
For the temporary relief of minor aches and pains associated with:
- headache
- muscular aches
- minor arthritis pain
- menstrual cramps
- common cold
- backaches
- toothaches
temporarily reduces fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take more than 12 tablets in 24 hours, with other drugs containing acetaminophen, 3 or more alcoholic drinks every day.
Do Not Use
- 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 you are allergic to acetaminophen or any of the inactive ingredients in the 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 persistent
- these could be signs of a serious condition
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Overdose warning: 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 and children 12 years and over: take 2 tablets every 4-6 hours as needed. Do not take more than 12 tablets in 24 hours, unless directed by a doctor.
- children ages 6-11: take 1 tablet every 4-6 hours as needed. Do not take more than 6 tablets in 24 hours, unless directed by a doctor.
- under 6 years of age: ask a doctor.
Other Information
- store between 68-77°F (20-25°C)
- do not use if safety seal is broken
Inactive Ingredients
magnesium stearate, povidone, silicon dioxide, sodium carboxymethyl starch, starch, stearic acid
Package Label.Principal Display Panel
Label (20260615115103684)
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