Anti-diarrheal Tablet
FDA Label NDC 57896-381

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceutical Corp for the product Anti-diarrheal (NDC 57896-381). 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 caplet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(In Each Caplet)

Loperamide HCI 2 mg

Purpose

Anti-diarrheal

Uses

  • controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI


Do not use

  • if you have bloody or black stool

    • Ask a doctor before use if you have

    • fever
    • mucus present in your stool
    • a history of liver disease

      • Ask a doctor or pharmacist before use if you are

      • taking antibiotics

        • When using this product

        • tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

          • Stop use and ask a doctor if

          • diarrhea lasts for more than 2 days
          • symptoms get worse
          • you get abdominal swelling
          • these may be signs of a serious condition

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

drink plenty of clear fluids to help prevent dehydration,which may accompany diarrhea

  • do not exceed recommended dose
  • Adults and children 12 years and over: 2 caplets after the first loose bowel movement; 1 caplet after each subsequent loose bowel movement; do not exceed 4 caplets in 24 hours
  • Children under 12 years: Ask a doctor

Other Information

  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

cellulose, corn starch, D C Yellow #10, dicalcium phosphate, FD C Blue #1, magnesium stearate, silica gel

Otc - Questions

Questions or comments? call 1-800-540-3765

Package Label


NDC 57896-381-48

GERICARE

Anti-Diarrheal

Loperamide HCl

Controls the symptoms of diarrhea

*compare to the active ingredient in imodium A-D

48 caplets

2 mg each

Tamper Evident: Do not use if imprinted seal under cap is broken or missing

* Please review the disclaimer below.