Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 0dd97bfb-67ce-472f-9b23-15f613bb3135

Route

ORAL

Published

Effective Date 2019-08-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2018-10-25

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

^†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.

DISTRIBUTED BY

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue

Wayne, PA 19087

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

L0000108

Rev # 03/19

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 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels 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

Premier Value ^®

†COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM ^® A-D

Loperamide HCl Soft Gelatin Capsules, 2 mg

Anti-Diarrheal

Suitable for adults and children 12 years and over

12 Softgels*

*Each Liquid-filled capsule contains 2 mg loperamide HCl

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)

^†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.

DISTRIBUTED BY

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue

Wayne, PA 19087

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

L0000108

Rev # 03/19

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 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels 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

Premier Value ^®

†COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM ^® A-D

Loperamide HCl Soft Gelatin Capsules, 2 mg

Anti-Diarrheal

Suitable for adults and children 12 years and over

12 Softgels*

*Each Liquid-filled capsule contains 2 mg loperamide HCl

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": "† 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. DISTRIBUTED BY Pharmacy Value Alliance, LLC 407 East Lancaster Avenue Wayne, PA 19087 If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. L0000108 Rev # 03/19", "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 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels 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": "Premier Value ® †COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM ® A-D Loperamide HCl Soft Gelatin Capsules, 2 mg Anti-Diarrheal Suitable for adults and children 12 years and over 12 Softgels* *Each Liquid-filled capsule contains 2 mg loperamide HCl", "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: 2026-02-15T12:00:27.068255 · Updated: 2026-03-14T23:00:53.570671