LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride tablet 
Preferred Pharmaceuticals Inc.

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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
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.

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 to 11 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 side 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
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code .: TS/DRUGS/22/2009

Relabeled By: Preferred Pharmaceuticals Inc.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (4 x 6's Tablets)

AUROHEALTH
Relabeled By: Preferred Pharmaceuticals Inc.
NDC 68788-8393
*Compare to the active
ingredient of Imodium® A-D

Loperamide Hydrochloride
Tablets USP 2 mg

Anti-Diarrheal

Controls the symptoms of diarrhea

24 Tablets

Loperamide HCL Tablets USP 2mg

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8393(NDC:58602-701)
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:68788-8393-24 in 1 CARTON03/01/2023
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20654803/01/2023
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8393)

Revised: 6/2024
Document Id: f1775ae4-649a-444d-8c7b-74bd753f0740
Set id: 5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf
Version: 3
Effective Time: 20240625
 
Preferred Pharmaceuticals Inc.