Better Living Brands Llc Anti-diarrheal/anti-gas Drug Facts

SPL v4

SPL

SPL Set ID 53829e72-d22c-434d-a108-1972081a6efb

Route

ORAL

Published

Effective Date 2024-07-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loperamide (2 mg) Dimethicone (125 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: L0R1;2;125 Shape: oval Color: white Size: 17 mm Score: 2

Marketing Status

ANDA Completed Since 2018-10-10 Until 2021-07-31

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

Uses

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

Purposes

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 caplet contains: calcium 165 mg, sodium 3 mg
•
store between 20^°-25^°C (68^°-77^°F). Protect from light.
•
do not use if printed blister unit is broken or torn

Inactive Ingredients

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, maltodextrin, microcrystalline cellulose, natural and artificial flavor, propylene glycol, stearic acid

Questions Or Comments?

1-800-719-9260

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. (1-800-222-1222)

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

Package/label Principal Display Panel

Signature care_®

Compare to Imodium^® Multi-Symptom Relief active ingredients

Quality Guaranteed

CAPLET

MULTI-SYMPTOM RELIEF

Anti-Diarrheal/Anti-Gas

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLETS, 2 mg/125 mg

Anti-diarrheal/Anti-gas

Actual Size

Relieves symptoms of diarrhea plus

• Cramps & Pressure

• Bloating

• Gas

24 CAPLETS*

*Capsule-shaped tablets

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Loperamide may interact with certain prescription drugs.

Structured Label Content

Uses

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

Purposes

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 (Do not use)

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

Other Information (Other information)

•
each caplet contains: calcium 165 mg, sodium 3 mg
•
store between 20^°-25^°C (68^°-77^°F). Protect from light.
•
do not use if printed blister unit is broken or torn

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, maltodextrin, microcrystalline cellulose, natural and artificial flavor, propylene glycol, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-719-9260

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. (1-800-222-1222)

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Signature care_®

Compare to Imodium^® Multi-Symptom Relief active ingredients

Quality Guaranteed

CAPLET

MULTI-SYMPTOM RELIEF

Anti-Diarrheal/Anti-Gas

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLETS, 2 mg/125 mg

Anti-diarrheal/Anti-gas

Actual Size

Relieves symptoms of diarrhea plus

• Cramps & Pressure

• Bloating

• Gas

24 CAPLETS*

*Capsule-shaped tablets

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": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACESULFAME POTASSIUM", "unii": "23OV73Q5G9", "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": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "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", "Purposes": "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 caplet contains: calcium 165 mg, sodium 3 mg • store between 20 ° -25 ° C (68 ° -77 ° F). Protect from light. • do not use if printed blister unit is broken or torn", "Inactive ingredients": "acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, maltodextrin, microcrystalline cellulose, natural and artificial flavor, propylene glycol, stearic acid", "Questions or comments?": "1-800-719-9260", "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. (1-800-222-1222)", "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", "Package/Label Principal Display Panel": "Signature care ® Compare to Imodium ® Multi-Symptom Relief active ingredients Quality Guaranteed CAPLET MULTI-SYMPTOM RELIEF Anti-Diarrheal/Anti-Gas LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLETS, 2 mg/125 mg Anti-diarrheal/Anti-gas Actual Size Relieves symptoms of diarrhea plus • Cramps & Pressure • Bloating • Gas 24 CAPLETS* *Capsule-shaped tablets", "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: 2026-02-15T12:03:19.730196 · Updated: 2026-03-14T23:03:21.577672