Ibs-10 Loperamide Simethicone

SPL v1

SPL

SPL Set ID 41d6dba5-e411-c8d2-e063-6294a90ae8fa

Route

ORAL

Published

Effective Date 2025-10-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (125 mg) Loperamide (2 mg)

Inactive Ingredients

Acesulfame Potassium Calcium Phosphate, Dibasic, Anhydrous Stearic Acid Cellulose, Microcrystalline Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance

Imprint: H;L21 Shape: capsule Color: white Size: 17 mm Score: 2

Marketing Status

ANDA Active Since 2025-10-23

Description

(in each tablet) Loperamide Hydrochloride USP 2 mg Simethicone USP 125 mg

Purpose

Anti-diarrheal Anti-gas

Medication Information

Purpose

Anti-diarrheal Anti-gas

Description

(in each tablet) Loperamide Hydrochloride USP 2 mg Simethicone USP 125 mg

Use(s)

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

Section 51945-4

Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg

Purposes

Anti-diarrheal

Anti-gas

Warnings

Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride

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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours
children 9-11 years (60-95 lbs)	1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours
children 6-8 years (48-59 lbs)	1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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

• if you have difficulty swallowing

Heart Alert

Taking more than directed can cause serious heart problems or death.

Other Information

• each tablet contains: calcium 640 mg, very low sodium and potassium 5.838 mg

• store between 20 to 25°C (68 to 77°F). Protect from light.

• do not use if carton is open or if blister unit is open or torn

Active Ingredient(s)

(in each tablet)

Loperamide Hydrochloride USP 2 mg

Simethicone USP 125 mg

Inactive Ingredients

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor

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 tablet

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

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. (1-800-222-1222)

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(s) (USE(S))

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

Section 51945-4 (51945-4)

Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg

Purposes (PURPOSES)

Anti-diarrheal

Anti-gas

Warnings (WARNINGS)

Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride

Directions (DIRECTIONS)

adults and children 12 years and over	2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours
children 9-11 years (60-95 lbs)	1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours
children 6-8 years (48-59 lbs)	1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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

• if you have difficulty swallowing

Heart Alert (HEART ALERT)

Taking more than directed can cause serious heart problems or death.

Other Information (OTHER INFORMATION)

Active Ingredient(s) (ACTIVE INGREDIENT(S))

(in each tablet)

Loperamide Hydrochloride USP 2 mg

Simethicone USP 125 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor

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 tablet

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

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. (1-800-222-1222)

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 (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": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LOPERAMIDE", "unii": "6X9OC3H4II", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ACESULFAME POTASSIUM", "unii": "23OV73Q5G9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas", "51945-4": "Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg", "PURPOSES": "Anti-diarrheal Anti-gas", "WARNINGS": "Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride", "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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9-11 years (60-95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours children 6-8 years (48-59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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 • if you have difficulty swallowing", "HEART ALERT": "Taking more than directed can cause serious heart problems or death.", "OTHER INFORMATION": "• each tablet contains: calcium 640 mg, very low sodium and potassium 5.838 mg • store between 20 to 25°C (68 to 77°F). Protect from light. • do not use if carton is open or if blister unit is open or torn", "ACTIVE INGREDIENT(S)": "(in each tablet) Loperamide Hydrochloride USP 2 mg Simethicone USP 125 mg", "INACTIVE INGREDIENTS": "acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor", "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 tablet If pregnant or breast-feeding , ask a health professional before use.", "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. (1-800-222-1222)", "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: 2026-02-15T12:08:50.212656 · Updated: 2026-03-14T23:13:15.147106