Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID ee8a6bdf-847e-4b88-8aea-6d3daa669994
Route
ORAL
Published
Effective Date 2025-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg)
Inactive Ingredients
Butylated Hydroxyanisole Fd&c Blue No. 1 Gelatin Glycerin Glyceryl Caprylate Polyoxyl 40 Hydrogenated Castor Oil Water

Identifiers & Packaging

Pill Appearance
Imprint: LP2 Shape: capsule Color: blue Size: 10 mm Score: 1
Marketing Status
NDA Active Since 2019-10-09

Description

Loperamide HCI 2 mg

Purpose

Anti-diarrheal


Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCI 2 mg

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5

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.

This product is not manufactured or distibuted by the owners of Imodium ®A-D.

Distributed by Target Corporation

Minneapolis, MN 55403

TM & ©2024 Target Brands, Inc.

L0000785

R0224

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

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 capsules after the first loose stool; 1 capsule after each subsequent loose stool; but no more than 4 capsules in 24 hours
Do Not Use
  • if you have bloody or black stool
  • in children under 12 years of age
Questions?

Call 1-888-235-2466  Mon - Fri 9AM - 5PM EST

24 Count Carton

Compare to active ingredient in Imodium ®A-D **

Anti-

Diarrheal

Loperamide hydrochloride

capsules, 2 mg

Controls the symptoms of diarrhea

Suitable for adults and children 12 years and over

up & up TM

24SOFTGELS *

*soft gelatin liquid-filled capsules

each softgel contains 2 mg loperamide HCI

ACTUAL SIZE

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, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

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.

Active Ingredient (in Each Capsule)

Loperamide HCI 2 mg

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the 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.


Structured Label Content

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5 (42229-5)

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.

This product is not manufactured or distibuted by the owners of Imodium ®A-D.

Distributed by Target Corporation

Minneapolis, MN 55403

TM & ©2024 Target Brands, Inc.

L0000785

R0224

Purpose

Anti-diarrheal

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

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 capsules after the first loose stool; 1 capsule after each subsequent loose stool; but no more than 4 capsules in 24 hours
Do Not Use (Do not use)
  • if you have bloody or black stool
  • in children under 12 years of age
Questions?

Call 1-888-235-2466  Mon - Fri 9AM - 5PM EST

24 Count Carton (24 count carton)

Compare to active ingredient in Imodium ®A-D **

Anti-

Diarrheal

Loperamide hydrochloride

capsules, 2 mg

Controls the symptoms of diarrhea

Suitable for adults and children 12 years and over

up & up TM

24SOFTGELS *

*soft gelatin liquid-filled capsules

each softgel contains 2 mg loperamide HCI

ACTUAL SIZE

Other Information (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 (Inactive ingredients)

butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Loperamide HCI 2 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

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


Advanced Ingredient Data


Raw Label Data

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