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Loperamide Hydrochloride by Aurohealth LLC

Medically reviewed on May 20, 2017

Dosage form: tablet
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: Aurohealth LLC
NDC Code: 58602-701

Drug Facts

Active ingredient (in each tablet)

Loperamide hydrochloride USP 2 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

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

Do not use

if you have bloody or black stool

Ask a doctor before use if you have
  • fever
  • mucus in the stool
  • a history of liver disease

Ask a doctor or pharmacist before use if you are

taking antibiotics

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. 

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 (1-800-222-1222) right away.

Directions
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • find right dose on chart. 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 to11 years (60 to 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 to 8 years (48 to 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 to 5 years (34 to 47 lbs)
ask a doctor
children under 2 years (up to 33 lbs)
do not use

Other information
  • store at 20° to 25°C (68° to 77°F).
  • do not use if carton or blister unit is open or torn
  • Meets USP dissolution test 2
  • see bottom panel for lot number and expiration date

Inactive ingredients

colloidal silicon dioxide, D & C yellow no. 10 aluminum lake, FD & C blue No. 1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate

Questions or comments?

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Code No.: TS/DRUGS/22/2009
Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg (24 Tablet Bottle)

AUROHEALTH

NDC 58602-701-07

Loperamide Hydrochloride
Tablets USP 2 mg

Anti-Diarrheal

Controls the symptoms of diarrhea

24 Tablets


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Container Carton (24's Tablets)

AUROHEALTH

NDC 58602-701-07

*Compare to the active
ingredient of Imodium® A-D

Loperamide Hydrochloride
Tablets USP 2 mg

Anti-Diarrheal

Controls the symptoms of diarrhea

24 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (2 x 6's Tablets)

AUROHEALTH

NDC 58602-701-04

*Compare to the active ingredient
of Imodium® A-D

Loperamide Hydrochloride
Tablets USP 2 mg

Anti-Diarrheal

Controls the symptoms of diarrhea

12 Tablets

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-701
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorGREEN (Light Green) Score2 pieces
ShapeCAPSULE (Biconvex) Size10mm
FlavorImprint CodeL;28
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-701-071 BOTTLE in 1 CARTON
124 TABLET in 1 BOTTLE
2NDC:58602-701-131 BOTTLE in 1 CARTON
248 TABLET in 1 BOTTLE
3NDC:58602-701-151 BOTTLE in 1 CARTON
360 TABLET in 1 BOTTLE
4NDC:58602-701-511 BOTTLE in 1 CARTON
472 TABLET in 1 BOTTLE
5NDC:58602-701-521 BOTTLE in 1 CARTON
596 TABLET in 1 BOTTLE
6NDC:58602-701-341 BOTTLE in 1 CARTON
6200 TABLET in 1 BOTTLE
7NDC:58602-701-451 BOTTLE in 1 CARTON
7500 TABLET in 1 BOTTLE
8NDC:58602-701-011 BLISTER PACK in 1 CARTON
86 TABLET in 1 BLISTER PACK
9NDC:58602-701-042 BLISTER PACK in 1 CARTON
96 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20654812/15/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited650381903ANALYSIS(58602-701), MANUFACTURE(58602-701)

 
Aurohealth LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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