LOPERAMIDE HYDROCHLORIDE capsule, liquid filled

LOPERAMIDE HYDROCHLORIDE by

Drug Labeling and Warnings

LOPERAMIDE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, APL HEALTHCARE 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 hydrochloride

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 the stool
• a history of liver disease
• a history of abnormal heart rhythm

ASK DOCTOR/PHARMACIST

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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° to 25°C (68° to 77°F) [See USP controlled room temperature]. Protect from light.
• do not use if carton or blister unit is open or torn
• avoid excessive heat above 40°C (104°F)
• see side panel for lot number and expiration date
• FDA approved dissolution test specifications differ from USP.

Inactive ingredients

butylated hydroxyanisole, gelatin, glycerin, glyceryl monocaprylate, neelicert FD&C Blue No.1, polyoxyl 40 hydrogenated castor oil, purified water

Questions or comments?

call toll free 1-855-274-4122 

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg (24 Softgels) Blister Carton Label

AUROHEALTH

NDC: 58602-727-76

†Compare to the active ingredient
          in Imodium® A-D

Loperamide Hydrochloride
Capsules USP, 2 mg
(Soft Gelatin Capsules)
Anti-Diarrheal

Controls the symptoms of diarrhea
Suitable for adults and children 12 years and over

Actual Size

24 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: 58602-727
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)
GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	BLUE (Pale blue to blue)	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	LO2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-727-74	1 in 1 CARTON	12/29/2025
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 58602-727-75	2 in 1 CARTON	12/29/2025
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 58602-727-80	3 in 1 CARTON	12/29/2025
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 58602-727-76	4 in 1 CARTON	12/29/2025
4		6 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	ANDA220372	12/29/2025

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650844777	ANALYSIS(58602-727) , MANUFACTURE(58602-727)