LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride capsule, liquid filled 
Dr. Reddy's Laboratories Inc.

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Loperamide Hydrochloride Capsules USP, 2 mg, liquid filled
Drug Facts

Active Ingredient (in each capsule)

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 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.

Directions

Other information

Inactive ingredients

butylated hydroxyanisole, FD&C Blue #1, gelatin, glycerol, glyceryl mono caprylo caprate, polyoxyl 40 hydrogenated castor oil, purified water,

printing ink white-edible oil – dewaxed bleached shellac resins, propylene glycol, sodium lauryl sulphate, titanium dioxide.                         

Questions or comments?

Questions or Comments? call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784

Distributed by:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in india

**All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Imodium® A-D

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

**COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM ® A-D

Loperamide Hydrochloride Capsules USP, 2 mg

Anti-Diarrheal

Suitable for adults and children 12 years and over

12 Softgels*

*each Liquid-filled capsule contains 2 mg Loperamide Hydrochloride, USP

Placeholder

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75907-097
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
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
SHELLAC (UNII: 46N107B71O)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize10mm
FlavorImprint Code L2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75907-097-121 in 1 CARTON08/01/2023
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:75907-097-242 in 1 CARTON08/01/2023
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21307010/22/2021
Labeler - Dr. Reddy's Laboratories Inc. (802315887)
Establishment
NameAddressID/FEIBusiness Operations
Strides Pharma Science Limited918513263analysis(75907-097) , manufacture(75907-097) , pack(75907-097)

Revised: 6/2023
Document Id: cefb1fd9-768f-c7a4-b9b1-ab7faaa67308
Set id: 356d9432-d948-4b88-b297-9161b845f86b
Version: 1
Effective Time: 20230625
 
Dr. Reddy's Laboratories Inc.