Loperamide Hydrochloride Tablet
FDA Label NDC 53329-664

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Loperamide Hydrochloride (NDC 53329-664). 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, 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 Caplet)

Loperamide HCI 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 HCI

Do Not Use

If you have bloody or black stool

Ask A Doctor Before Use If You Have

  • fever
  • mucus in the 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 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 (1-800-222-1222).

Directions

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
    adults and children 12 years and over 2 caplets after the first loose stool;
    1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
    children 9-11 years
    (60-95 lbs)     		1 caplet after the first loose stool;
    ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
    children 6-8 years
    (48-59 lbs)     		1 caplet after the first loose stool;
    ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
    children under 6 years
    (up to 47 lbs)     		ask a doctor

Other Information

  • store between 20 ° – 25 ° C (68 ° – 77 ° F)
  • see side panel for lot number and expiration date
  • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive Ingredients

Anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions?

Call 1-800-MEDLINE (633-5463)

Principal Display Panel

MEDLINE

NDC 53329-664-57

†Compare to the active ingredient in Imodium®A-D

LOPERAMIDE HCl TABLETS USP, 2 mg

ANTI-DIARRHEAL

Controls The Symptoms of Diarrhea

2 mg

12 Caplets *

Each Caplet ( *capsule-shaped tablet)

contains Loperamide HCl USP, 2 mg

Distributed by: Medline Industries, Inc.

5099015/1012

* Please review the disclaimer below.