LOPERAMIDE HYDROCHLORIDE capsule, liquid filled

Loperamide Hydrochloride by

Drug Labeling and Warnings

Loperamide Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc, Strides Pharma Science Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• if you have bloody or black stool
• in children under 12 years of age

Ask a doctor before use if you have

• fever
• mucus in 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 right away.

Directions

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
• not for use in children under 12 years of age
• adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other information

• store at 20°-25°C (68°-77°F). Protect from Light.
• avoid excessive heat above 40°C (104°F)
• do not use if carton or blister unit is open or torn
• see side panel for lot number and expiration date

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?

go to www.strides.com or call Strides Pharma Inc. weekdays from 9 AM to 5 PM EST at 1-877-244-9825

Manufactured by:

Strides Pharma Science Limited

Bengaluru-562106, India.

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Issued: 06/2020

†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: 59556-959-06

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

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-959
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	L2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-959-06	1 in 1 CARTON	10/22/2021
1	NDC: 59556-959-03	12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 59556-959-05	2 in 1 CARTON	10/22/2021
2	NDC: 59556-959-03	12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213070	10/22/2021

Labeler - Strides Pharma Inc (078868278)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Pharma Science Limited		918513263	ANALYSIS(59556-959) , MANUFACTURE(59556-959) , PACK(59556-959)