Bion Loperamide Simethicone Tablets

SPL v3

SPL

SPL Set ID 9b0a802f-6fae-4142-ad2f-4b16ed67400e

Route

ORAL

Published

Effective Date 2021-10-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loperamide (2 mg) Dimethicone (125 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: LS1 Shape: capsule Color: white Size: 17 mm Score: 2

Marketing Status

ANDA Active Since 2021-12-01

Description

Drug Facts

Purpose

Anti-diarrheal Anti-gas

Medication Information

Purpose

Anti-diarrheal Anti-gas

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50567-7

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

Section 53414-9

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

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 years to 11 years (60 lbs to 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 years to 8 years (48 lbs to 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 years to 5 years (34 lbsto 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

Allergy Alert

Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Other Information

each caplet contains: calcium 155 mg, sodium 3 mg
store between 20° to 25°C (68° to 77°F). Protect from light.

Inactive Ingredients

acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor

Questions Or Comments?

call toll-free 1-888-235-2466

Principal Display Panel

*** Compare to the active ingredients in Imodium ^® Multi-Symptom Relief

NDC 69452-210-04

Loperamide HCl

and Simethicone Tablets,

2 mg/125 mg

Antidiarrheal/Anti-gas

Multi-Symptom Relief

Caplet

Relieves symptoms of diarrhea plus

Cramps & Pressure
Bloating
Gas

Actual Size

6 Caplets*

*Capsule-shaped Tablets

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

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

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50567-7 (50567-7)

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

Section 53414-9 (53414-9)

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

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 years to 11 years (60 lbs to 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 years to 8 years (48 lbs to 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 years to 5 years (34 lbsto 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

Allergy Alert (Allergy alert)

Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Other Information (Other information)

each caplet contains: calcium 155 mg, sodium 3 mg
store between 20° to 25°C (68° to 77°F). Protect from light.

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor

Questions Or Comments? (Questions or comments?)

call toll-free 1-888-235-2466

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

*** Compare to the active ingredients in Imodium ^® Multi-Symptom Relief

NDC 69452-210-04

Loperamide HCl

and Simethicone Tablets,

2 mg/125 mg

Antidiarrheal/Anti-gas

Multi-Symptom Relief

Caplet

Relieves symptoms of diarrhea plus

Cramps & Pressure
Bloating
Gas

Actual Size

6 Caplets*

*Capsule-shaped Tablets

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

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

Advanced Ingredient Data

[{"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": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VANILLA", "unii": "Q74T35078H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas", "42229-5": "Drug Facts", "50565-1": "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)", "50567-7": "When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.", "50568-5": "Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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 years to 11 years (60 lbs to 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 years to 8 years (48 lbs to 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 years to 5 years (34 lbsto 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", "Allergy alert": "Do not use if you have ever had a rash or other allergic reaction to loperamide HCl", "Other information": "each caplet contains: calcium 155 mg, sodium 3 mg store between 20° to 25°C (68° to 77°F). Protect from light.", "Inactive ingredients": "acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor", "Questions or comments?": "call toll-free 1-888-235-2466", "PRINCIPAL DISPLAY PANEL": "*** Compare to the active ingredients in Imodium ® Multi-Symptom Relief NDC 69452-210-04 Loperamide HCl and Simethicone Tablets, 2 mg/125 mg Antidiarrheal/Anti-gas Multi-Symptom Relief Caplet Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas Actual Size 6 Caplets* *Capsule-shaped Tablets", "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", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:39.703297 · Updated: 2026-03-14T23:11:20.857564