Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID c62bc8d4-0857-16fc-e053-2a95a90a0c41

Route

ORAL

Published

Effective Date 2022-12-30

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 2021-07-02

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 not manufactured or distributed by the 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.

Scan here for more

information or

call 1-888-423-0139

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO BMAA0521

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

√ QUALITY GUARANTEED

L0000460

Lot #

Expiration Date

Rev # 06/21

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

24's Carton

+TopCareTM

health

NDC 36800-208-12

COMPARE TO

IMODIUM® A-D

ACTIVE INGREDIENT†

Anti-Diarrheal

LOPERAMIDE HCl

SOFT GELATIN CAPSULES, 2 mg

Controls the Symptoms

of Diarrhea

Suitable for Adults & Children

12 years and over

actual size

24 SOFTGELS*

*each liquid-filled capsule

contains 2 mg Loperamide HCl

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 1-888-423-0139

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 not manufactured or distributed by the 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.

Scan here for more

information or

call 1-888-423-0139

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO BMAA0521

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

√ QUALITY GUARANTEED

L0000460

Lot #

Expiration Date

Rev # 06/21

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

24's Carton (24's carton)

+TopCareTM

health

NDC 36800-208-12

COMPARE TO

IMODIUM® A-D

ACTIVE INGREDIENT†

Anti-Diarrheal

LOPERAMIDE HCl

SOFT GELATIN CAPSULES, 2 mg

Controls the Symptoms

of Diarrhea

Suitable for Adults & Children

12 years and over

actual size

24 SOFTGELS*

*each liquid-filled capsule

contains 2 mg Loperamide HCl

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 1-888-423-0139

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": "†This product is not manufactured or distributed by the 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. Scan here for more information or call 1-888-423-0139 DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO BMAA0521 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com √ QUALITY GUARANTEED L0000460 Lot # Expiration Date Rev # 06/21", "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", "24's carton": "+TopCareTM health NDC 36800-208-12 COMPARE TO IMODIUM® A-D ACTIVE INGREDIENT† Anti-Diarrheal LOPERAMIDE HCl SOFT GELATIN CAPSULES, 2 mg Controls the Symptoms of Diarrhea Suitable for Adults & Children 12 years and over actual size 24 SOFTGELS* *each liquid-filled capsule contains 2 mg Loperamide HCl", "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 1-888-423-0139", "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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:27.832130 · Updated: 2026-03-14T23:00:53.570671