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SPL v1

SPL

SPL Set ID 462db53c-e286-425b-a9d9-0c39eef84d04

Route

ORAL

Published

Effective Date 2022-06-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loperamide (2 mg)

Inactive Ingredients

Fd&c Blue No. 1 Butylated Hydroxyanisole Gelatin Glycerin Glyceryl Caprylate/caprate Polyoxyl 40 Hydrogenated Castor Oil Shellac Propylene Glycol Sodium Lauryl Sulfate Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: L2 Shape: oval Color: blue Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2024-06-30

Description

Loperamide Hydrochloride USP, 2 mg

Purpose

Anti-diarrheal

Medication Information

Purpose

Anti-diarrheal

Description

Loperamide Hydrochloride USP, 2 mg

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

Section 51727-6

Inactive ingredients butylated hydroxyanisole, FD&C Blue #1, gelatin, glycerol, glyceryl mono caprylo caprate, polyoxyl 40 hydrogenated castor oil, purified water, printing ink white-edible oil – dewaxed bleached shellac resins, propylene glycol, sodium lauryl sulphate, titanium dioxide.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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

Questions Or Comments?

Dial 1-877-244-9825 on weekdays from 9 AM to 5 PM EST.

Manufactured by:

Strides Pharma Science Limited

Bengaluru-562106, India.

Distributed by:

Rite Aid

30 Hunter Lane, Camp Hill,

PA 17011.

Revised: 06/2022

^†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.

Stop Use and Ask A Doctor

symptoms get worse
diarrhea lasts for more than 2 days
you get abdominal swelling or bulging. These may be signs of a serious condition.

Active Ingredient (in Each Capsule)

Loperamide Hydrochloride USP, 2 mg

Ask A Doctor Before Use If You Have

fever
mucus in stool
a history of liver disease
a history of abnormal heart rhythm

Package Label.principal Display Panel

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

NDC 11822-959-06

Loperamide Hydrochloride Capsules USP, 2 mg

Anti-Diarrheal

Suitable for adults and children 12 years and over

12 Softgels*

^* each Liquid-filled capsule contains 2 mg Loperamide Hydrochloride, USP

Structured Label Content

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

Section 51727-6 (51727-6)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

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

Questions Or Comments? (Questions or comments?)

Dial 1-877-244-9825 on weekdays from 9 AM to 5 PM EST.

Manufactured by:

Strides Pharma Science Limited

Bengaluru-562106, India.

Distributed by:

Rite Aid

30 Hunter Lane, Camp Hill,

PA 17011.

Revised: 06/2022

^†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.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

symptoms get worse
diarrhea lasts for more than 2 days
you get abdominal swelling or bulging. These may be signs of a serious condition.

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

Loperamide Hydrochloride USP, 2 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

fever
mucus in stool
a history of liver disease
a history of abnormal heart rhythm

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

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

NDC 11822-959-06

Loperamide Hydrochloride Capsules USP, 2 mg

Anti-Diarrheal

Suitable for adults and children 12 years and over

12 Softgels*

^* each Liquid-filled capsule contains 2 mg Loperamide Hydrochloride, USP

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "controls symptoms of diarrhea, including Travelers' Diarrhea", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.", "50568-5": "Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.", "51727-6": "Inactive ingredients butylated hydroxyanisole, FD&C Blue #1, gelatin, glycerol, glyceryl mono caprylo caprate, polyoxyl 40 hydrogenated castor oil, purified water, printing ink white-edible oil – dewaxed bleached shellac resins, propylene glycol, sodium lauryl sulphate, titanium dioxide. ", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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", "Questions or comments?": "Dial 1-877-244-9825 on weekdays from 9 AM to 5 PM EST. Manufactured by: Strides Pharma Science Limited Bengaluru-562106, India. Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011. Revised: 06/2022 † 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 .", "Stop use and ask a doctor": "symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition.", "Active Ingredient (in each capsule)": "Loperamide Hydrochloride USP, 2 mg", "Ask a doctor before use if you have": "fever mucus in stool a history of liver disease a history of abnormal heart rhythm", "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "† COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM ® A-D NDC 11822-959-06 Loperamide Hydrochloride Capsules USP, 2 mg Anti-Diarrheal Suitable for adults and children 12 years and over 12 Softgels* * each Liquid-filled capsule contains 2 mg Loperamide Hydrochloride, USP"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:13.095472 · Updated: 2026-03-14T23:03:10.704753