Loperamide Hcl Capsules - Leader

SPL v4

SPL

SPL Set ID bd58d6e9-628c-4c6b-b44c-da95e0417ba7

Route

ORAL

Published

Effective Date 2024-05-31

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 2019-01-21

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

CardinalHealth ^TM

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

All LEADER ^TM Brand Products Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied.

^†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ^® A-D.

CARDINAL HEALTH, the Cardinal Health LOGO,

ESSENTIAL TO CARE, LEADER, and the LEADER LOGO

are trademarks or registered trademarks of

Cardinal Health. All other marks are the property

of their respective owners.

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.

Manufactured for:

BIONPHARMA

Princeton, NJ 08540

L0000786

Lot#

Expiration Date

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

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

Questions Or Comments?

call toll free 1-888-235-2466

Principal Display Panel

LEADER _TM

NDC 70000-0461-1

Anti-Diarrheal

Loperamide Hydrochloride Capsules, 2 mg

Controls the Symptoms of Diarrhea

Suitable for Adults and Children

12 years and over

24 SOFTGELS*

*Each Liquid-Filled Capsule

Contains 2 mg Loperamide HCl

Actual Size

COMPARE TO

IMODIUM ® A-D

active ingredient ^†

100 % Money Back Guarantee

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)

CardinalHealth ^TM

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

All LEADER ^TM Brand Products Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied.

^†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ^® A-D.

CARDINAL HEALTH, the Cardinal Health LOGO,

ESSENTIAL TO CARE, LEADER, and the LEADER LOGO

are trademarks or registered trademarks of

Cardinal Health. All other marks are the property

of their respective owners.

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.

Manufactured for:

BIONPHARMA

Princeton, NJ 08540

L0000786

Lot#

Expiration Date

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

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

Questions Or Comments? (Questions or comments?)

call toll free 1-888-235-2466

Principal Display Panel

LEADER _TM

NDC 70000-0461-1

Anti-Diarrheal

Loperamide Hydrochloride Capsules, 2 mg

Controls the Symptoms of Diarrhea

Suitable for Adults and Children

12 years and over

24 SOFTGELS*

*Each Liquid-Filled Capsule

Contains 2 mg Loperamide HCl

Actual Size

COMPARE TO

IMODIUM ® A-D

active ingredient ^†

100 % Money Back Guarantee

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

[{"name": "BUTYLATED HYDROXYANISOLE", "unii": "REK4960K2U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL CAPRYLATE", "unii": "TM2TZD4G4A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LOPERAMIDE", "unii": "6X9OC3H4II", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "controls symptoms of diarrhea, including Travelers' Diarrhea", "42229-5": "CardinalHealth TM DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 All LEADER TM Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. † This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ® A-D. © 2018 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. 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. Manufactured for: BIONPHARMA Princeton, NJ 08540 L0000786 Lot# Expiration Date 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": "if you have bloody or black stool in children under 12 years of age", "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", "Questions or comments?": "call toll free 1-888-235-2466", "Principal Display Panel": "LEADER TM NDC 70000-0461-1 Anti-Diarrheal Loperamide Hydrochloride Capsules, 2 mg Controls the Symptoms of Diarrhea Suitable for Adults and Children 12 years and over 24 SOFTGELS* *Each Liquid-Filled Capsule Contains 2 mg Loperamide HCl Actual Size COMPARE TO IMODIUM ® A-D active ingredient † 100 % Money Back Guarantee", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:08.598843 · Updated: 2026-03-14T23:03:01.087200