LOPERAMIDE HYDROCHLORIDE - loperamide hydrochloride capsule, liquid filled 
RITE AID CORPORATION

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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 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?

Dial 1-877-244-9825 on weekdays from 9 AM to 5 PM EST.

Manufactured by:

Strides Pharma Science Limited

Bengaluru-562106, India.

Distributed by:

Rite Aid

30 Hunter Lane, Camp Hill,

PA 17011.

Revised: 06/2022

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

NDC 11822-959-06

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

Carton Label
LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-9590
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
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:11822-9590-52 in 1 CARTON06/30/2024
1NDC:11822-9590-312 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11822-9590-612 in 1 CARTON06/30/2024
2NDC:11822-9590-312 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21307006/30/2024
Labeler - RITE AID CORPORATION (014578892)
Registrant - Strides Pharma Global Pte. Ltd. (659220961)
Establishment
NameAddressID/FEIBusiness Operations
Strides Pharma Science Limited918513263ANALYSIS(11822-9590) , MANUFACTURE(11822-9590) , PACK(11822-9590)

Revised: 6/2022
Document Id: 904a0931-c5a2-4b6f-a65d-cd8b53cdf658
Set id: 462db53c-e286-425b-a9d9-0c39eef84d04
Version: 1
Effective Time: 20220609
 
RITE AID CORPORATION