Kroger 44-375

SPL v7

SPL

SPL Set ID 49049c95-b19c-4ff0-a1bd-bc7b4193e875

Route

ORAL

Published

Effective Date 2025-09-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loperamide (2 mg)

Inactive Ingredients

Starch, Corn D&c Yellow No. 10 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 44;375 Shape: oval Color: green Size: 10 mm Score: 2

Marketing Status

ANDA Active Since 2020-05-06

Description

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl 2 mg

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

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
find right dose on chart. If possible, use weight to dose; otherwise, use age.

adults and children 12 years and over	2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs)	1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs)	1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children 2-5 years (34 to 47 lbs)	ask a doctor
children under 2 years (up to 33 lbs)	do not use

Do Not Use

if you have bloody or black stool

Other Information

each caplet contains: calcium 15 mg
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store between 20°-25°C (68°-77°F)
see end flap for expiration date and lot number

Inactive Ingredients

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments?

Call 1-800-632-6900

Principal Display Panel

NDC 30142-775-08

Kroger _®

health

COMPARE TOTHEACTIVE

INGREDIENT IN IMODIUM^® A-D*

Anti-Diarrheal

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal

CONTROLS THE SYMPTOMS

OF DIARRHEA

ACTUAL SIZE

24 CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

1. To open, tear

at perforations and

remove a section.

2. Use ✄ to cut

through plastic

for caplet.

*IMODIUM^® is a registered trademark of Kenvue Inc. Kenvue Inc. is not

affiliated with The Kroger Co. or this product.

50844 REV0325A37508

PROUDLY DISTRIBUTED

BY THE KROGER CO.

CINCINNATI, OHIO 45202

‡OUR PHARMACIST RECOMMENDED

Quality Guaranteed

Kroger.com/guarantee

800-632-6900

FOR MORE PRODUCT INFORMATION, SCAN UPC

USING YOUR KROGER APP OR CALL 800-632-6900

Kroger 44-375

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 Caplet)

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

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

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
find right dose on chart. If possible, use weight to dose; otherwise, use age.

adults and children 12 years and over	2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs)	1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs)	1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children 2-5 years (34 to 47 lbs)	ask a doctor
children under 2 years (up to 33 lbs)	do not use

Do Not Use (Do not use)

if you have bloody or black stool

Other Information (Other information)

each caplet contains: calcium 15 mg
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store between 20°-25°C (68°-77°F)
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments? (Questions or comments?)

Call 1-800-632-6900

Principal Display Panel

NDC 30142-775-08

Kroger _®

health

COMPARE TOTHEACTIVE

INGREDIENT IN IMODIUM^® A-D*

Anti-Diarrheal

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal

CONTROLS THE SYMPTOMS

OF DIARRHEA

ACTUAL SIZE

24 CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

1. To open, tear

at perforations and

remove a section.

2. Use ✄ to cut

through plastic

for caplet.

*IMODIUM^® is a registered trademark of Kenvue Inc. Kenvue Inc. is not

affiliated with The Kroger Co. or this product.

50844 REV0325A37508

PROUDLY DISTRIBUTED

BY THE KROGER CO.

CINCINNATI, OHIO 45202

‡OUR PHARMACIST RECOMMENDED

Quality Guaranteed

Kroger.com/guarantee

800-632-6900

FOR MORE PRODUCT INFORMATION, SCAN UPC

USING YOUR KROGER APP OR CALL 800-632-6900

Kroger 44-375

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 Caplet) (Active ingredient (in each caplet))

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": "LOPERAMIDE", "unii": "6X9OC3H4II", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10 ALUMINUM LAKE", "unii": "CQ3XH3DET6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "controls symptoms of diarrhea, including Travelers’ Diarrhea", "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 find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use", "Do not use": "if you have bloody or black stool", "Other information": "each caplet contains: calcium 15 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store between 20°-25°C (68°-77°F) see end flap for expiration date and lot number", "Inactive ingredients": "corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide", "Questions or comments?": "Call 1-800-632-6900", "Principal Display Panel": "NDC 30142-775-08 Kroger ® health COMPARE TOTHEACTIVE INGREDIENT IN IMODIUM ® A-D* Anti-Diarrheal Loperamide Hydrochloride Tablets, 2 mg Anti-Diarrheal CONTROLS THE SYMPTOMS OF DIARRHEA ACTUAL SIZE 24 CAPLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 1. To open, tear at perforations and remove a section. 2. Use ✄ to cut through plastic for caplet. *IMODIUM ® is a registered trademark of Kenvue Inc. Kenvue Inc. is not affiliated with The Kroger Co. or this product. 50844 REV0325A37508 PROUDLY DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 ‡OUR PHARMACIST RECOMMENDED Quality Guaranteed Kroger.com/guarantee 800-632-6900 FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900 Kroger 44-375", "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 caplet)": "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: 2026-02-15T12:07:01.206494 · Updated: 2026-03-14T23:10:11.873456