Biogesic
FDA Label NDC 45737-610

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Generic Corporation for the product Biogesic (NDC 45737-610). 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, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, 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 ingredients (in each caplet)                      Purpose

Acetaminophen 500 mg                                            Pain Reliever/Fever Reducer

Dexbrompheniramine maleate 1 mg                            Antihistamine

Otc - Purpose

Purpose

Antihistamine

Nasal Decongestant

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.
Liver Warning: This product contains Acetaminophen. Severe liver damage may
occur if you take 

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

    • 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
    • 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:

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

          • Warnings:

          • May cause drowsiness: alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product.
          • Do not take this product if you are taking sedatives or tranquilizers, without consulting your doctor.
          • Use caution when driving motor vehicle or operating machinery.

            • 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. 

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a Health Professional before use.

Dosage & Administration

Directions: Do not exceed recommended dosage

adults and children
12 years of age and over

Take 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 acetaminophen and could cause liver damage.

Indications & Usage

Uses

  • For the temporary relief of minor aches and pains associated with
  • headache
  • muscular aches
  • backaches
  • minor arthiritis pain
  • common cold
  • toothaches
  • mentrual cramps
  • temporarily reduces fever
  • itchy and watery eyes due to hay fever

Inactive Ingredient

Inactive ingredients: dicalcium phasphate, microcrystalline cellulose, povidone, silicon dioxide, sodium carboxymethyl starch, starch, stearic acid, talc.

Otc - Questions

Questions or comments?

1-305-403-3788

* Please review the disclaimer below.