LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE - loperamide hydrochloride and simethicone tablet 
Aurohealth LLC

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Drug Facts

Active ingredients (in each caplet) 

Loperamide HCl USP 2 mg
Simethicone USP 125 mg

Purposes

Anti-diarrheal
Anti-gas

Uses

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

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

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


When using this product

tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

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)

Directions

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

Other information

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label

Healthy Living

LOPERAMIDE HCl AND SIMETHICONE 
tablets 2 mg/125 mg

Multi-Sympton Relief
C
aplet
Loperamide HCl 2 mg - Antidiarrheal 
Simethicone 125 mg - Anti-gas
** Compare
to the active
ingridients of 
Imodium®
Multi-Sympton
Relief
Relieves symptoms of diarrhea
plus

•  Cramps & Pressure     •   Bloating    •  Gas   

T    79
24 Caplets*
*capsule-shaped tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (12 Caplets) Blister Carton Label

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 
loperamide hydrochloride and simethicone tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-868
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITE (off-white) Score2 pieces
ShapeCAPSULESize17mm
FlavorVANILLAImprint Code T;79
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-868-764 in 1 CARTON02/24/2021
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21105902/24/2021
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(58602-868) , MANUFACTURE(58602-868)

Revised: 12/2023
Document Id: 525b4db8-d35b-4d35-84fa-ed4b1f2f8a33
Set id: d388f536-704a-4d6e-ab27-c1a96e939413
Version: 4
Effective Time: 20231202
 
Aurohealth LLC