Loperamide And Simethicone Caplets

Loperamide And Simethicone Caplets
SPL v2
SPL
SPL Set ID 1b79204e-8a99-455b-84d6-f381fd7d1135
Route
ORAL
Published
Effective Date 2021-06-01
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 2021-06-01
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 caplet 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


NDC 53041-263-50

Multi-Symptom Relief Caplet

Loperamide Hydrochloride and Simethicone

Tablets, 2 mg/125 mg

Anti-diarrheal/Anti-gas

Relieves symptoms of diarrhea plus

Cramps & Pressure

Bloating

Gas



6 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 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

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 caplet 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)


NDC 53041-263-50

Multi-Symptom Relief Caplet

Loperamide Hydrochloride and Simethicone

Tablets, 2 mg/125 mg

Anti-diarrheal/Anti-gas

Relieves symptoms of diarrhea plus

Cramps & Pressure

Bloating

Gas



6 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 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:34.352911 · Updated: 2026-03-14T22:59:37.411151