Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 06f99f59-e702-49f1-bb1d-e7cf58c54c30

Route

ORAL

Published

Effective Date 2022-08-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Loperamide (2 mg) Dimethicone (125 mg)

Inactive Ingredients

Calcium Silicate Silicon Dioxide Anhydrous Dibasic Calcium Phosphate Microcrystalline Cellulose Stearic Acid Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: NA Shape: capsule Color: white Size: 16 mm Score: 1

Marketing Status

ANDA Active Since 2022-01-13

Description

Loperamide HCl USP, 2 mg Simethicone USP, 125 mg

Purpose

Anti-diarrheal Anti-gas

Medication Information

Purpose

Anti-diarrheal Anti-gas

Description

Loperamide HCl USP, 2 mg Simethicone USP, 125 mg

Uses

relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Section 42229-5

Manufactured by:

Sun Pharmaceutical

Industries Limited,

MOHALI, INDIA

Distributed by:

Ohm Laboratories Inc.,

New Brunswick,

NJ 08901

Purposes

Anti-diarrheal

Anti-gas

Directions

•
drink plenty of clear fluids to help prevent dehydration caused by diarrhea
•
take only on an empty stomach (1 hour before or 2 hours after a meal)
•
take with a full (8 oz.) glass of water
•
find right dose on chart below. 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 (upto 33 lbs)	do not use

Do Not Use

•
if you have bloody or black stool
•
if you have difficulty swallowing

Questions?

call 1-800-406-7984

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

Other Information

•
calcium: contains 142 mg/caplet
•
store between 20-25° C (68-77° F). Protect from light.
•
TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive Ingredients

calcium silicate, colloidal silicon dioxide, dibasic calcium phosphate, microcrystalline cellulose, sodium starch glycolate, stearic acid

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.
•
you have difficulty swallowing the caplet

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 (1800-222-1222).

Active Ingredients (in Each Caplet)

Loperamide HCl USP, 2 mg

Simethicone USP, 125 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.

Principal Display Panel 12 Caplet Blister Pack Carton

^†Compare To

the active ingredients of

Imodium^®

Multi-Symptom Relief

NDC 51660-069-12

ohm^®

Loperamide HCl and

Simethicone Tablets,

2 mg/125 mg

Anti-Diarrheal/Anti-Gas

Multi-Symptom Relief

Relieves symptoms of diarrhea plus

Cramps & Pressure
Bloating
Gas

12 CAPLETS*

(*capsule-shaped tablets)

Principal Display Panel 18 Caplet Blister Pack Carton

^†Compare To

the active ingredients of

Imodium^®

Multi-Symptom Relief

NDC 51660-069-18

ohm^®

Loperamide HCl and

Simethicone Tablets,

2 mg/125 mg

Anti-Diarrheal/Anti-Gas

Multi-Symptom Relief

Relieves symptoms of diarrhea plus

Cramps & Pressure
Bloating
Gas

18 CAPLETS*

(*capsule-shaped tablets)

Principal Display Panel 24 Caplet Blister Pack Carton

^†Compare To

the active ingredients of

Imodium^®

Multi-Symptom Relief

NDC 51660-069-24

ohm^®

Loperamide HCl and

Simethicone Tablets,

2 mg/125 mg

Anti-Diarrheal/Anti-Gas

Multi-Symptom Relief

Relieves symptoms of diarrhea plus

Cramps & Pressure
Bloating
Gas

24 CAPLETS*

(*capsule-shaped tablets)

Principal Display Panel 6 Capsule Blister Pack Carton

^†Compare To

the active ingredients of

Imodium^®

Multi-Symptom Relief

NDC 51660-069-06

ohm^®

Loperamide HCl and

Simethicone Tablets,

2 mg/125 mg

Anti-Diarrheal/Anti-Gas

Multi-Symptom Relief

Relieves symptoms of diarrhea plus

Cramps & Pressure
Bloating
Gas

6 CAPLETS*

(*capsule-shaped tablets)

Structured Label Content

Uses

relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Section 42229-5 (42229-5)

Manufactured by:

Sun Pharmaceutical

Industries Limited,

MOHALI, INDIA

Distributed by:

Ohm Laboratories Inc.,

New Brunswick,

NJ 08901

Purposes

Anti-diarrheal

Anti-gas

Directions

•
drink plenty of clear fluids to help prevent dehydration caused by diarrhea
•
take only on an empty stomach (1 hour before or 2 hours after a meal)
•
take with a full (8 oz.) glass of water
•
find right dose on chart below. 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 (upto 33 lbs)	do not use

Do Not Use (Do not use)

•
if you have bloody or black stool
•
if you have difficulty swallowing

Questions?

call 1-800-406-7984

Allergy Alert: (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

Other Information (Other information)

•
calcium: contains 142 mg/caplet
•
store between 20-25° C (68-77° F). Protect from light.
•
TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive Ingredients (Inactive ingredients)

calcium silicate, colloidal silicon dioxide, dibasic calcium phosphate, microcrystalline cellulose, sodium starch glycolate, stearic acid

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.
•
you have difficulty swallowing the caplet

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 (1800-222-1222).

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Loperamide HCl USP, 2 mg

Simethicone USP, 125 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.

Principal Display Panel 12 Caplet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton)

^†Compare To

the active ingredients of

Imodium^®

Multi-Symptom Relief

NDC 51660-069-12

ohm^®

Loperamide HCl and

Simethicone Tablets,

2 mg/125 mg

Anti-Diarrheal/Anti-Gas

Multi-Symptom Relief

Relieves symptoms of diarrhea plus

Cramps & Pressure
Bloating
Gas

12 CAPLETS*

(*capsule-shaped tablets)

Principal Display Panel 18 Caplet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton)

^†Compare To

the active ingredients of

Imodium^®

Multi-Symptom Relief

NDC 51660-069-18

ohm^®

Loperamide HCl and

Simethicone Tablets,

2 mg/125 mg

Anti-Diarrheal/Anti-Gas

Multi-Symptom Relief

Relieves symptoms of diarrhea plus

Cramps & Pressure
Bloating
Gas

18 CAPLETS*

(*capsule-shaped tablets)

Principal Display Panel 24 Caplet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton)

^†Compare To

the active ingredients of

Imodium^®

Multi-Symptom Relief

NDC 51660-069-24

ohm^®

Loperamide HCl and

Simethicone Tablets,

2 mg/125 mg

Anti-Diarrheal/Anti-Gas

Multi-Symptom Relief

Relieves symptoms of diarrhea plus

Cramps & Pressure
Bloating
Gas

24 CAPLETS*

(*capsule-shaped tablets)

Principal Display Panel 6 Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton)

^†Compare To

the active ingredients of

Imodium^®

Multi-Symptom Relief

NDC 51660-069-06

ohm^®

Loperamide HCl and

Simethicone Tablets,

2 mg/125 mg

Anti-Diarrheal/Anti-Gas

Multi-Symptom Relief

Relieves symptoms of diarrhea plus

Cramps & Pressure
Bloating
Gas

6 CAPLETS*

(*capsule-shaped tablets)

Advanced Ingredient Data

[{"name": "LOPERAMIDE", "unii": "6X9OC3H4II", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CALCIUM SILICATE", "unii": "S4255P4G5M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas", "42229-5": "Manufactured by: Sun Pharmaceutical Industries Limited, MOHALI, INDIA Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901", "Purposes": "Anti-diarrheal Anti-gas", "Directions": "• drink plenty of clear fluids to help prevent dehydration caused by diarrhea • take only on an empty stomach (1 hour before or 2 hours after a meal) • take with a full (8 oz.) glass of water • find right dose on chart below. 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 (upto 33 lbs) do not use", "Do not use": "• if you have bloody or black stool • if you have difficulty swallowing", "Questions?": "call 1-800-406-7984", "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", "Other information": "• calcium: contains 142 mg/caplet • store between 20-25° C (68-77° F). Protect from light. • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.", "Inactive ingredients": "calcium silicate, colloidal silicon dioxide, dibasic calcium phosphate, microcrystalline cellulose, sodium starch glycolate, stearic acid", "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. • you have difficulty swallowing the caplet", "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 (1800-222-1222).", "Active ingredients (in each caplet)": "Loperamide HCl USP, 2 mg Simethicone USP, 125 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.", "PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton": "† Compare To the active ingredients of Imodium ® Multi-Symptom Relief NDC 51660-069-12 ohm ® Loperamide HCl and Simethicone Tablets, 2 mg/125 mg Anti-Diarrheal/Anti-Gas Multi-Symptom Relief Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 12 CAPLETS* (*capsule-shaped tablets)", "PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton": "† Compare To the active ingredients of Imodium ® Multi-Symptom Relief NDC 51660-069-18 ohm ® Loperamide HCl and Simethicone Tablets, 2 mg/125 mg Anti-Diarrheal/Anti-Gas Multi-Symptom Relief Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 18 CAPLETS* (*capsule-shaped tablets)", "PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton": "† Compare To the active ingredients of Imodium ® Multi-Symptom Relief NDC 51660-069-24 ohm ® Loperamide HCl and Simethicone Tablets, 2 mg/125 mg Anti-Diarrheal/Anti-Gas Multi-Symptom Relief Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 24 CAPLETS* (*capsule-shaped tablets)", "PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton": "† Compare To the active ingredients of Imodium ® Multi-Symptom Relief NDC 51660-069-06 ohm ® Loperamide HCl and Simethicone Tablets, 2 mg/125 mg Anti-Diarrheal/Anti-Gas Multi-Symptom Relief Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 6 CAPLETS* (*capsule-shaped tablets)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:18.101193 · Updated: 2026-03-14T23:00:41.107943