Anti-diarrheal/ Anti-gas Multi-symptom Relief

SPL v2

SPL

SPL Set ID 2c4f882b-89d5-42ce-e063-6294a90a5fbe

Route

ORAL

Published

Effective Date 2025-02-05

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Loperamide (2 mg) Dimethicone (125 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: 2;63 Shape: capsule Color: white Size: 16 mm Score: 2

Marketing Status

ANDA Active Since 2025-02-05

Description

Loperamide HCl 2 mg Simethicone 125 mg

Purpose

Anti-diarrheal Anti-gas

Medication Information

Purpose

Anti-diarrheal

Anti-gas

Description

Loperamide HCl 2 mg Simethicone 125 mg

Use(s)

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

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
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; 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 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

Other Information

each 10 mL contains: calcium 180 mg, sodium 3 mg
store between 20-25°C (68-77°F). Protect from light.
do not use if blister unit is torn or broken

Inactive Ingredients

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid

Questions Or Comments

Call 1-609-860-2600 (Monday-Friday 8 am- 4 pm)

Principal Display Panel

Harris Teeter™

NDC 69256-265-31

MULTI-SYMPTOM RELIEF

ANTI-DIARRHEAL/ANTI-GAS

Loperamide Hydrochloride and Simethicone

Tablets, 2 mg/125 mg

Relieves Symptoms of Diarrhea Plus

Cramps & Pressure

Bloating, Gas

Compare to the active ingredients in Imodium®

Multi-Symptom Relief Caplet*

12 Caplets**

**Capsule-Shaped Tablets

Harris Teeter™

NDC 69256-265-73

MULTI-SYMPTOM RELIEF

ANTI-DIARRHEAL/ANTI-GAS

Loperamide Hydrochloride and Simethicone

Tablets, 2 mg/125 mg

Relieves Symptoms of Diarrhea Plus

Cramps & Pressure

Bloating, Gas

Compare to the active ingredients in Imodium®

Multi-Symptom Relief Caplet*

18 Caplets**

**Capsule-Shaped Tablets

Harris Teeter™

NDC 69256-265-33

MULTI-SYMPTOM RELIEF

ANTI-DIARRHEAL/ANTI-GAS

Loperamide Hydrochloride and Simethicone

Tablets, 2 mg/125 mg

Relieves Symptoms of Diarrhea Plus

Cramps & Pressure

Bloating, Gas

Compare to the active ingredients in Imodium®

Multi-Symptom Relief Caplet*

24 Caplets**

**Capsule-Shaped Tablets

When Using This Product

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

Stop Use and Ask 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

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)

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredients (in Each Caplet)

Loperamide HCl 2 mg

Simethicone 125 mg

Ask A Doctor Before Use If the Child Has

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

Purpose (PURPOSE)

Anti-diarrheal

Anti-gas

Warnings (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 (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; 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 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

Other Information (OTHER INFORMATION)

each 10 mL contains: calcium 180 mg, sodium 3 mg
store between 20-25°C (68-77°F). Protect from light.
do not use if blister unit is torn or broken

Inactive Ingredients (INACTIVE INGREDIENTS)

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid

Questions Or Comments (QUESTIONS OR COMMENTS)

Call 1-609-860-2600 (Monday-Friday 8 am- 4 pm)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Harris Teeter™

NDC 69256-265-31

MULTI-SYMPTOM RELIEF

ANTI-DIARRHEAL/ANTI-GAS

Loperamide Hydrochloride and Simethicone

Tablets, 2 mg/125 mg

Relieves Symptoms of Diarrhea Plus

Cramps & Pressure

Bloating, Gas

Compare to the active ingredients in Imodium®

Multi-Symptom Relief Caplet*

12 Caplets**

**Capsule-Shaped Tablets

Harris Teeter™

NDC 69256-265-73

MULTI-SYMPTOM RELIEF

ANTI-DIARRHEAL/ANTI-GAS

Loperamide Hydrochloride and Simethicone

Tablets, 2 mg/125 mg

Relieves Symptoms of Diarrhea Plus

Cramps & Pressure

Bloating, Gas

Compare to the active ingredients in Imodium®

Multi-Symptom Relief Caplet*

18 Caplets**

**Capsule-Shaped Tablets

Harris Teeter™

NDC 69256-265-33

MULTI-SYMPTOM RELIEF

ANTI-DIARRHEAL/ANTI-GAS

Loperamide Hydrochloride and Simethicone

Tablets, 2 mg/125 mg

Relieves Symptoms of Diarrhea Plus

Cramps & Pressure

Bloating, Gas

Compare to the active ingredients in Imodium®

Multi-Symptom Relief Caplet*

24 Caplets**

**Capsule-Shaped Tablets

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 Doctor If (STOP USE AND ASK 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

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)

If Pregnant Or Breast Feeding, (IF PREGNANT OR BREAST FEEDING,)

ask a health professional before use.

Active Ingredients (in Each Caplet) (ACTIVE INGREDIENTS (in each caplet))

Loperamide HCl 2 mg

Simethicone 125 mg

Ask A Doctor Before Use If the Child Has (ASK A DOCTOR BEFORE USE IF THE CHILD HAS)

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": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ACESULFAME POTASSIUM", "unii": "23OV73Q5G9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "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": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas", "PURPOSE": "Anti-diarrheal Anti-gas", "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 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; 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 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", "OTHER INFORMATION": "each 10 mL contains: calcium 180 mg, sodium 3 mg store between 20-25°C (68-77°F). Protect from light. do not use if blister unit is torn or broken", "INACTIVE INGREDIENTS": "acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid", "QUESTIONS OR COMMENTS": "Call 1-609-860-2600 (Monday-Friday 8 am- 4 pm)", "PRINCIPAL DISPLAY PANEL": "Harris Teeter™ NDC 69256-265-31 MULTI-SYMPTOM RELIEF ANTI-DIARRHEAL/ANTI-GAS Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg Relieves Symptoms of Diarrhea Plus Cramps & Pressure Bloating, Gas Compare to the active ingredients in Imodium® Multi-Symptom Relief Caplet* 12 Caplets** **Capsule-Shaped Tablets Harris Teeter™ NDC 69256-265-73 MULTI-SYMPTOM RELIEF ANTI-DIARRHEAL/ANTI-GAS Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg Relieves Symptoms of Diarrhea Plus Cramps & Pressure Bloating, Gas Compare to the active ingredients in Imodium® Multi-Symptom Relief Caplet* 18 Caplets** **Capsule-Shaped Tablets Harris Teeter™ NDC 69256-265-33 MULTI-SYMPTOM RELIEF ANTI-DIARRHEAL/ANTI-GAS Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg Relieves Symptoms of Diarrhea Plus Cramps & Pressure Bloating, Gas Compare to the active ingredients in Imodium® Multi-Symptom Relief Caplet* 24 Caplets** **Capsule-Shaped Tablets", "WHEN USING THIS PRODUCT": "tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.", "STOP USE AND ASK 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", "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)", "IF PREGNANT OR BREAST FEEDING,": "ask a health professional before use.", "ACTIVE INGREDIENTS (in each caplet)": "Loperamide HCl 2 mg Simethicone 125 mg", "ASK A DOCTOR BEFORE USE IF THE CHILD HAS": "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: 2026-02-15T12:05:29.410406 · Updated: 2026-03-14T23:07:22.014703