SPL v3
SPL
SPL Set ID 12940c3b-dc58-31fb-e063-6294a90ae880
Route
ORAL
Published
Effective Date 2025-01-10
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 101 Microcrystalline Cellulose 102 Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: T;79 Shape: capsule Color: white Size: 17 mm Score: 2
Marketing Status
ANDA Active Since 2024-02-17

Description

Active ingredients (in each caplet)  Loperamide HCl USP 2 mg Simethicone USP 125 mg

Purpose

Anti-diarrheal Anti-gas


Medication Information

Purpose

Anti-diarrheal Anti-gas

Description

Active ingredients (in each caplet)  Loperamide HCl USP 2 mg Simethicone USP 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 to 11 years (60 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 to 8 years (48 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 to 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
Drug Facts

Active ingredients (in each caplet) 

Loperamide HCl USP 2 mg

Simethicone USP 125 mg

Other Information
  • each caplet contains: calcium 165 mg, sodium 4 mg
  • store between 20° to 25°C (68° to 77°F). Protect from light.
  • do not use if carton is opened or if individual blister units are torn or opened
Inactive Ingredients

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

Questions Or Comments?

call 1-888-287-1915

(Monday – Friday 8:30 AM to 5:00 PM EST)



DISTRIBUTED BY:

Walmart Inc.,

Bentonville, AR 72716



Made in India

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)

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.



Package Label Principal Display Panel 2 Mg/125mg (24 Caplets) Blister Carton Label

NDC 79903-223-24



Compare

to Imodium®

Multi-Sympton

Relief active

ingridients**




equate



Loperamide Hydrochloride

and Simethicone Tablets

2 mg/125 mg




Anti-Diarrheal/

Anti-Gas



Multi-Sympton Relief

C
aplet



Relieves symptoms

of diarrhea
plus

•  Cramps & Pressure

•   Bloating

•  Gas



Actual Size



24

CAPLETS*

*capsule-Shaped

Tablets






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 to 11 years (60 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 to 8 years (48 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 to 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
Drug Facts

Active ingredients (in each caplet) 

Loperamide HCl USP 2 mg

Simethicone USP 125 mg

Other Information (Other information)
  • each caplet contains: calcium 165 mg, sodium 4 mg
  • store between 20° to 25°C (68° to 77°F). Protect from light.
  • do not use if carton is opened or if individual blister units are torn or opened
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

call 1-888-287-1915

(Monday – Friday 8:30 AM to 5:00 PM EST)



DISTRIBUTED BY:

Walmart Inc.,

Bentonville, AR 72716



Made in India

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)

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.



Package Label Principal Display Panel 2 Mg/125mg (24 Caplets) Blister Carton Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label)

NDC 79903-223-24



Compare

to Imodium®

Multi-Sympton

Relief active

ingridients**




equate



Loperamide Hydrochloride

and Simethicone Tablets

2 mg/125 mg




Anti-Diarrheal/

Anti-Gas



Multi-Sympton Relief

C
aplet



Relieves symptoms

of diarrhea
plus

•  Cramps & Pressure

•   Bloating

•  Gas



Actual Size



24

CAPLETS*

*capsule-Shaped

Tablets






Advanced Ingredient Data


Raw Label Data

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