SPL v5
SPL
SPL Set ID 9dd3a6d6-9fff-45b3-8e76-57bf5ee2e07f
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 2020-12-14
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 1-855-274-4122

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



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



Code: AP/DRUGS/04/2016

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

AUROHEALTH

NDC 58602-815-76

** Compare to the active

ingridients of  Imodium® Multi-Sympton Relief

Loperamide HCl and

Simethicone Tablets

2 mg/125 mg



Loperamide HCl 2 mg - Antidiarrheal 

Simethicone 125 mg - Anti-gas

Multi-Sympton Relief

C aplet

Relieves symptoms of diarrhea plus

•  Cramps & Pressure

•   Bloating

•  Gas   

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 1-855-274-4122

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



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



Code: AP/DRUGS/04/2016

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)

AUROHEALTH

NDC 58602-815-76

** Compare to the active

ingridients of  Imodium® Multi-Sympton Relief

Loperamide HCl and

Simethicone Tablets

2 mg/125 mg



Loperamide HCl 2 mg - Antidiarrheal 

Simethicone 125 mg - Anti-gas

Multi-Sympton Relief

C aplet

Relieves symptoms of diarrhea plus

•  Cramps & Pressure

•   Bloating

•  Gas   

24 Caplets*

*capsule-shaped tablets





Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:18.503314 · Updated: 2026-03-14T23:06:55.199519