drug facts

drug facts

SPL v4

SPL

SPL Set ID 01434d38-2c9d-4222-adb8-cf7b4909cac8

Route

oral

Published

Effective Date 2022-05-24

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: P13 Shape: capsule Color: blue Size: 10 mm Score: 1

Marketing Status

nda completed Since 2018-12-15 Until 2025-10-31

Purpose

Anti-diarrheal

Description

Loperamide HCl 2 mg

Medication Information

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

Purpose

Anti-diarrheal

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

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

Description

Loperamide HCl 2 mg

Principal Display Panel

sunmark TM

COMPARE TO IMODIUM ® A-D

ACTIVE INGREDIENT†

NDC 70677-0060-1

anti-diarrheal

Loperamide HCl Soft Gelatin Capsules, 2 mg

Suitable for adults and children

12 years and over

Controls the symptoms of diarrhea

24 SOFTGELS*

*each liquid-filled capsule contains 2 mg loperamide HCl

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.

MCKESSON

Another Quality Product

Distributed by Mckesson

6555 State Highway 161, Irving, TX 75039

Money Back Guarantee

Please visit us at www.sunmarkbrand.com

Lot #

Expiration Date

Do Not Use

if you have bloody or black stool
in children under 12 years of age

Questions Or Comments?

call toll free 1-888-235-2466

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 HCl 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

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

Purpose

Anti-diarrheal

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

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

Principal Display Panel

sunmark TM

COMPARE TO IMODIUM ® A-D

ACTIVE INGREDIENT†

NDC 70677-0060-1

anti-diarrheal

Loperamide HCl Soft Gelatin Capsules, 2 mg

Suitable for adults and children

12 years and over

Controls the symptoms of diarrhea

24 SOFTGELS*

*each liquid-filled capsule contains 2 mg loperamide HCl

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.

MCKESSON

Another Quality Product

Distributed by Mckesson

6555 State Highway 161, Irving, TX 75039

Money Back Guarantee

Please visit us at www.sunmarkbrand.com

Lot #

Expiration Date

Do Not Use (Do not use)

if you have bloody or black stool
in children under 12 years of age

Questions Or Comments? (Questions or comments?)

call toll free 1-888-235-2466

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 HCl 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. MCKESSON Another Quality Product Distributed by Mckesson 6555 State Highway 161, Irving, TX 75039 Money Back Guarantee Please visit us at www.sunmarkbrand.com Lot # Expiration Date", "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": "sunmark TM COMPARE TO IMODIUM ® A-D ACTIVE INGREDIENT† NDC 70677-0060-1 anti-diarrheal Loperamide HCl Soft Gelatin Capsules, 2 mg Suitable for adults and children 12 years and over Controls the symptoms of diarrhea 24 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 HCl 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: 2026-02-15T12:02:40.656906 · Updated: 2026-03-14T23:02:21.986500