loperamide hydrochloride and simethicone tablets, 2 mg/125 mg (otc)

SPL v1

SPL

SPL Set ID 0199a50f-f367-40e7-8af0-745a959d3fde

Route

oral

Published

Effective Date 2025-04-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

loperamide (2 mg) dimethicone (125 mg)

Inactive Ingredients

acesulfame potassium croscarmellose sodium anhydrous dibasic calcium phosphate microcrystalline cellulose stearic acid

Identifiers & Packaging

Pill Appearance

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

Marketing Status

anda active Since 2024-06-30

Purpose

Anti-diarrheal Anti-gas

Description

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

Medication Information

Warnings

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

Heart alert:Taking more than directed can cause serious heart problems or death

Purpose

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 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

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

Inactive Ingredients

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

Description

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

Principal Display Panel

Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-1x6's carton

Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-6's foil

Use(s)

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

Section 53414-9

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

Purposes

Anti-diarrheal

Anti-gas

Do Not Use

• if you have bloody or black stool

• if you have difficulty swallowing

Active Ingredient(s)

(in each tablet)

Loperamide Hydrochloride USP 2 mg

Simethicone USP 125 mg

Questions Or Comments

call 1-888-588-1418

Manufactured for FSA Store Inc.

473 Blair Rd Suite 100

PMB 24308 Dallas, TX 75231

Customer Help Line: 1-888-588-1418

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

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

Structured Label Content

Warnings (WARNINGS)

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

Heart alert:Taking more than directed can cause serious heart problems or death

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

Other Information (OTHER INFORMATION)

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-1x6's carton

Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-6's foil

Use(s) (USE(S))

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

Section 53414-9 (53414-9)

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

Purposes (PURPOSES)

Anti-diarrheal

Anti-gas

Do Not Use (DO NOT USE)

• if you have bloody or black stool

• if you have difficulty swallowing

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

(in each tablet)

Loperamide Hydrochloride USP 2 mg

Simethicone USP 125 mg

Questions Or Comments (QUESTIONS OR COMMENTS)

call 1-888-588-1418

Manufactured for FSA Store Inc.

473 Blair Rd Suite 100

PMB 24308 Dallas, TX 75231

Customer Help Line: 1-888-588-1418

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

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

Advanced Ingredient Data

[{"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": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "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)

{"USE(S)": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "PURPOSES": "Anti-diarrheal Anti-gas", "WARNINGS": "Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride 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 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", "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", "QUESTIONS OR COMMENTS": "call 1-888-588-1418 Manufactured for FSA Store Inc. 473 Blair Rd Suite 100 PMB 24308 Dallas, TX 75231 Customer Help Line: 1-888-588-1418", "PRINCIPAL DISPLAY PANEL": "Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-1x6's carton Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-6's foil", "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", "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: 2026-02-15T12:05:52.051331 · Updated: 2026-03-14T23:08:14.770901