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SPL v1

SPL

SPL Set ID a3687b81-1f4d-49d5-a25f-b16560ab83d8

Route

ORAL

Published

Effective Date 2025-05-20

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 2025-05-01

Description

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl 2 mg

Use

Controls symptoms of diarrhea, including Traveler's 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 liquids 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 (34-47 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.

Questions?

Call toll-free 1-844-912-4012

Other Information

do not use if seal around caplet is broken or damaged
store between 20º and 25ºC (68º and 77ºF)

Inactive Ingredients

corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

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 (1-800-222-1222) right away.

Principal Display Panel 12 Caplets

NDC 37835-131-12

Compare to active ingredient in Imodium ^®A-D ^†

ANTI-DIARRHEAL

CAPLETS*

Loperamide HCl Tablets, 2 mg

ANTI-DIARRHEAL

Controls the symptoms of diarrhea

Original Prescription Strength

12 Caplets*

Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg)

^†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ^®A-D.

Distributed by BI-MART, Eugene, OR 97402

Principal Display Panel 24 Caplets

NDC 37835-131-24

Compare to active ingredient in Imodium ^®A-D ^†

ANTI-DIARRHEAL

CAPLETS*

Loperamide HCl Tablets, 2 mg

ANTI-DIARRHEAL

Controls the symptoms of diarrhea

Original Prescription Strength

24 Caplets*

Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg)

^†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ^®A-D.

Distributed by BI-MART, Eugene, OR 97402

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

Principal Display Panel 100 Caplets

NDC 37835-131-01

Compare to active ingredient in Imodium ^®A-D ^†

ANTI-DIARRHEAL

CAPLETS*

Loperamide HCl Tablets, 2 mg

ANTI-DIARRHEAL

Controls the symptoms of diarrhea

Original Prescription Strength

100 Caplets*

Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg)

^†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ^®A-D.

Distributed by BI-MART, Eugene, OR 97402

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 Traveler's 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 liquids 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 (34-47 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.

Questions?

Call toll-free 1-844-912-4012

Other Information (Other information)

do not use if seal around caplet is broken or damaged
store between 20º and 25ºC (68º and 77ºF)

Inactive Ingredients (Inactive ingredients)

corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

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 (1-800-222-1222) right away.

Principal Display Panel 12 Caplets (Principal Display Panel-12 Caplets)

NDC 37835-131-12

Compare to active ingredient in Imodium ^®A-D ^†

ANTI-DIARRHEAL

CAPLETS*

Loperamide HCl Tablets, 2 mg

ANTI-DIARRHEAL

Controls the symptoms of diarrhea

Original Prescription Strength

12 Caplets*

Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg)

^†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ^®A-D.

Distributed by BI-MART, Eugene, OR 97402

Principal Display Panel 24 Caplets (Principal Display Panel-24 Caplets)

NDC 37835-131-24

Compare to active ingredient in Imodium ^®A-D ^†

ANTI-DIARRHEAL

CAPLETS*

Loperamide HCl Tablets, 2 mg

ANTI-DIARRHEAL

Controls the symptoms of diarrhea

Original Prescription Strength

24 Caplets*

Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg)

^†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ^®A-D.

Distributed by BI-MART, Eugene, OR 97402

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

Principal Display Panel 100 Caplets (Principal Display Panel-100 Caplets)

NDC 37835-131-01

Compare to active ingredient in Imodium ^®A-D ^†

ANTI-DIARRHEAL

CAPLETS*

Loperamide HCl Tablets, 2 mg

ANTI-DIARRHEAL

Controls the symptoms of diarrhea

Original Prescription Strength

100 Caplets*

Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg)

^†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ^®A-D.

Distributed by BI-MART, Eugene, OR 97402

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": "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": ""}, {"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 Traveler's 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 liquids 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 (34-47 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.", "Questions?": "Call toll-free 1-844-912-4012 ", "Other information": "do not use if seal around caplet is broken or damaged store between 20º and 25ºC (68º and 77ºF)", "Inactive ingredients": "corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel", "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 (1-800-222-1222) right away.", "Principal Display Panel-12 Caplets": "NDC 37835-131-12 Compare to active ingredient in Imodium ® A-D † ANTI-DIARRHEAL CAPLETS* Loperamide HCl Tablets, 2 mg ANTI-DIARRHEAL Controls the symptoms of diarrhea Original Prescription Strength 12 Caplets* Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg) † This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ® A-D. Distributed by BI-MART , Eugene, OR 97402", "Principal Display Panel-24 Caplets": "NDC 37835-131-24 Compare to active ingredient in Imodium ® A-D † ANTI-DIARRHEAL CAPLETS* Loperamide HCl Tablets, 2 mg ANTI-DIARRHEAL Controls the symptoms of diarrhea Original Prescription Strength 24 Caplets* Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg) † This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ® A-D. Distributed by BI-MART , Eugene, OR 97402", "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", "Principal Display Panel-100 Caplets": "NDC 37835-131-01 Compare to active ingredient in Imodium ® A-D † ANTI-DIARRHEAL CAPLETS* Loperamide HCl Tablets, 2 mg ANTI-DIARRHEAL Controls the symptoms of diarrhea Original Prescription Strength 100 Caplets* Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg) † This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ® A-D. Distributed by BI-MART , Eugene, OR 97402", "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: 2026-02-15T12:06:10.419886 · Updated: 2026-03-14T23:08:47.595357