Duralgina Tablet
FDA Label NDC 53145-013

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 (NDC 53145-013). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient (in each tablet)

Acetaminophen 325 mg

Otc - Purpose

Purpose

Pain reliever/Fever reducer

Indications & Usage

Uses

For the temporary relief of minor aches and pains associated with 

  • headache
  • muscular aches
  • minor arthritis pain
  • menstrual cramps
  • common cold
  • temporarily reduces fever
  • backaches
  • toothaches

Warnings

Warnings:

Liver warning:

This product contains acetaminophen. Sever liver damage may occur if you take

  • more than12 tablets in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day.

    • Do not use:

    • with any other drug conatining 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 docor or pharmacist before use if you are taking the blood thinning drug warfarin

      Stop using this product 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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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.

Dosage & Administration

Directions:

  • Do not take more than directed (see overdose warning)
    •  Adults and children12 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

Inactive Ingredient

Inactive ingredients Magnesium stearate, povidone, silicone dioxide, sodium carboxymethyl, starch, stearic acid

Otc - Questions

Questions: Call 1-800-560-5223 M-F 9AM - 4PM Eastern

Package Label.Principal Display Panel

Image Description (Durolgina)

Image Description (Durolgina)

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