LOPERAMIDE HYDROCHLORIDE - loperamide hydrochloride tablet 
Aurohealth LLC

----------

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 seal over bottle opening is broken or missing
  • 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 (96 Tablet Bottle)

NDC 58602-827-52
Primary Health

Anti-Diarrheal
         Loperamide
      Hydrochloride
Tablets USP 2 mg

Controls the symptoms of diarrhea

96 Tablets


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg (96 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg  Carton (96's Tablets)

NDC 58602-827-52
Primary Health

COMPARE TO Imodium®
A-D active ingredent*

Anti-Diarrheal 
         Loperamide
      Hydrochloride
Tablets USP 2 mg

Controls the
symptoms of diarrhea 

96 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg  Carton (96's Tablets)

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-827
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorGREEN (Light Green) Score2 pieces
ShapeCAPSULE (Biconvex) Size10mm
FlavorImprint Code L;28
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-827-521 in 1 CARTON12/15/201510/04/2019
196 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20654812/15/201510/04/2019
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-827) , MANUFACTURE(58602-827)

Revised: 9/2019
 
Aurohealth LLC