Loperamide Hydrochloride Capsule, Liquid Filled
FDA Label NDC 75907-097

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddy's Laboratories Inc. for the product Loperamide Hydrochloride (NDC 75907-097). 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 capsule), purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Capsule)

Loperamide Hydrochloride USP, 2 mg

Purpose

Anti-diarrheal

Use

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 HCl

Heart alert: Taking more than directed can cause serious heart problems or death

Do Not Use

  • if you have bloody or black stool
  • in children under 12 years of age

Ask A Doctor Before Use If You Have

  • fever
  • mucus in stool
  • a history of liver disease
  • a history of abnormal heart rhythm

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Loperamide may interact with certain prescription drugs.

When Using This Product

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

Stop Use And Ask A Doctor If

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

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 caused by diarrhea.
  • not for use in children under 12 years of age
  • adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other Information

  • store at 20°-25°C (68°-77°F). Protect from Light.
  • avoid excessive heat above 40°C (104°F)
  • do not use if carton or blister unit is open or torn
  • see side panel for lot number and expiration date

Inactive Ingredients

butylated hydroxyanisole, FD&C Blue #1, gelatin, glycerol, glyceryl mono caprylo caprate, polyoxyl 40 hydrogenated castor oil, purified water,

printing ink white-edible oil – dewaxed bleached shellac resins, propylene glycol, sodium lauryl sulphate, titanium dioxide.                         

Questions Or Comments?

Questions or Comments? call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784

Distributed by:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in india

**All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Imodium® A-D

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label.Principal Display Panel

**COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM ® A-D

Loperamide Hydrochloride Capsules USP, 2 mg

Anti-Diarrheal

Suitable for adults and children 12 years and over

12 Softgels*

*each Liquid-filled capsule contains 2 mg Loperamide Hydrochloride, USP

* Please review the disclaimer below.