Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 812d636c-82d5-4eef-b154-cdf065943122

Route

ORAL

Published

Effective Date 2012-04-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Loperamide (2 mg)

Inactive Ingredients

Croscarmellose Sodium Crospovidone D&c Yellow No. 10 Fd&c Blue No. 1 Magnesium Stearate Powdered Cellulose Starch, Pregelatinized Corn Tristearin Anhydrous Lactose

Identifiers & Packaging

Pill Appearance

Imprint: 123 Shape: capsule Color: green Size: 9 mm Score: 2

Marketing Status

ANDA Active Since 2011-09-24

Description

Loperamide HCl USP, 2 mg

Purpose

Anti-diarrheal

Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl USP, 2 mg

Use(s)

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 HCI

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; ½ 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; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs)	ask a doctor

Do Not Use

if you have bloody or black stool

Questions?

call 1800-406-7984

Keep the carton. It contains important information.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

Other Information

store between 20° – 25° C (68° – 77° F)
see side panel for lot number and expiration date
TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive Ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Principal Display Panel

NDC 54868-6312-0

Loperamide HCl Tablets, USP 2 mg

Anti-Diarrheal

12 CAPLETS ^†

Each caplet ( ^† capsule-shaped tablet) contains Loperamide HCl, USP 2 mg

Controls The Symptoms of Diarrhea

^* Compare to the active ingredient of Imodium ^® A-D

When Using This Product

tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop Use and Ask A Doctor If

diarrhea lasts for more than 2 days
symptoms get worse
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 USP, 2 mg

Ask A Doctor Before Use If You Have

fever
mucus in the stool
a history of liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking antibiotics

Structured Label Content

Use(s) (USE(S))

controls symptoms of diarrhea, including Travelers’ Diarrhea

Purpose (PURPOSE)

Anti-diarrheal

Warnings (WARNINGS)

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI

Directions (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; ½ 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; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs)	ask a doctor

Do Not Use (Do not use)

if you have bloody or black stool

Questions? (QUESTIONS?)

call 1800-406-7984

Keep the carton. It contains important information.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

Other Information (OTHER INFORMATION)

store between 20° – 25° C (68° – 77° F)
see side panel for lot number and expiration date
TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive Ingredients (INACTIVE INGREDIENTS)

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 54868-6312-0

Loperamide HCl Tablets, USP 2 mg

Anti-Diarrheal

12 CAPLETS ^†

Each caplet ( ^† capsule-shaped tablet) contains Loperamide HCl, USP 2 mg

Controls The Symptoms of Diarrhea

^* Compare to the active ingredient of Imodium ^® A-D

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)

diarrhea lasts for more than 2 days
symptoms get worse
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 USP, 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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking antibiotics

Advanced Ingredient Data

[{"name": "LOPERAMIDE", "unii": "6X9OC3H4II", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, PREGELATINIZED CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISTEARIN", "unii": "P6OCJ2551R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "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 HCI", "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; ½ 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; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children under 6 years (up to 47 lbs) ask a doctor", "Do not use": "if you have bloody or black stool", "QUESTIONS?": "call 1800-406-7984 Keep the carton. It contains important information. Distributed by: Ohm Laboratories Inc. 1385 Livingston Avenue North Brunswick, NJ 08902", "OTHER INFORMATION": "store between 20° – 25° C (68° – 77° F) see side panel for lot number and expiration date TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.", "INACTIVE INGREDIENTS": "anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch", "PRINCIPAL DISPLAY PANEL": "NDC 54868-6312-0 Loperamide HCl Tablets, USP 2 mg Anti-Diarrheal 12 CAPLETS † Each caplet ( † capsule-shaped tablet) contains Loperamide HCl, USP 2 mg Controls The Symptoms of Diarrhea * Compare to the active ingredient of Imodium ® A-D", "When using this product": "tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.", "Stop use and ask a doctor if": "diarrhea lasts for more than 2 days symptoms get worse 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 USP, 2 mg", "Ask a doctor before use if you have": "fever mucus in the stool a history of liver disease", "Ask a doctor or pharmacist before use if you are": "taking antibiotics"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:26.547615 · Updated: 2026-03-14T22:53:04.035717