Dolofin
FDA Label NDC 53145-420

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 Dolofin (NDC 53145-420). 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:

Alcohol warning:

  • if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

    • Liver warning:

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

    • more than 6 tablets in 24 hours, which is the maximum daily amount
    • 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.
      • for more than 10 days for pain, unless directed by a doctor.
      • for more than 3 days for fever, unless directed by a doctor. 

        • Ask a doctor before use 

        • if you have liver disease
        • if you are taking the blood thinning drug warfarin.

          • Stop using this product and ask a doctor if:

          • symptoms do not improve
          • pain or fever persists or get worse
          • New symptoms occur
          • Redness or swelling is present
          • These could be signs of a serious condition

Otc - Pregnancy Or Breast Feeding

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the 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 6 tablets in 24 hours
    •  Adults and children12 years and over Take 1 tablet every 4-6 hours as needed, or as directed by a doctor.
     Children under 12 years Do not use this adult extra strength product in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminophen and could cause liver damage.

Inactive Ingredient

Inactive ingredients Dicalcium phosphate, microcrystalline cellulose, povidone, silicon dioxide, sodium carboxy methyl starch, stearic acid, talc

Otc - Questions

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

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Dolofin (Dolofin)

Dolofin (Dolofin)

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