Dologesic Tablet
FDA Label NDC 54859-010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceutical International Division for the product Dologesic (NDC 54859-010). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

(in each caplet)

Acetaminophen 500 mg

Dexbrompheniramine Maleate 1 mg

Purpose

Pain reliever/fever reducer

antihistamine

Uses

  • For the temporary relief of minor aches and pains associated with
  • headache
  • muscular aches
  • backaches
  • minor arthritis pain
  • common cold
  • toothaches
  • menstrual cramps
  • temporarily reduces fever

Warnings

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

  • more than 8 capsules in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminphen
  • 3 or more alcoholic drinks every day while using this product

    • Alcohol Warning: If you consumer 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.

    Do not use

    • with any other drug containing acetaminphen (prescription or non-prescription). If you are not sure whether a drug contains acetaminphen 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
    • May cause drowsiness: alcohol, sedative and tranquilizers may increase the drowsiness effect Avoid alcoholic beverages while taking this product
    • Do not take this product if you are taking sedative or tranquilizers without consulting your doctore
    • Use cauting when driving motor vehicle or operating machinery.

      • Ask a doctor or pharmacist before use: 

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

        • Stop using this product and ask a doctor if:

        • pain gets worse or last more than 10 days
        • fever gets worse or last more than 3 days
        • new symptoms occur
        • redness or swelling is present
        • these could be signs of a serious condition

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Pregnancy Or Breast Feeding

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

Directions

Overdose Warning: Taking more than recommended dose (overdose), may cause liver damage. In case of accidental overdose, contact a physician or Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Do not exceed recommended dosage

 AgeDose
 adults and children 12 years of age and overTake 2 caplets every 4-6 hours. Do not take more than 8 caplets in 24 hours, or as directed by a doctor 
 children under 12 years of age Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminphen and could cause liver damage

Inactive Ingredients

magnesium stearate, microcrystaline cellulose, sodium starch glycolate, tricalcium phosphate

Questions Or Comments

1-866-595-5598

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Dologesicdf (Dologesicdfcaps)

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