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NDC 58602-0701-02 Loperamide Hydrochloride 2 mg/1 Details

Loperamide Hydrochloride 2 mg/1

Loperamide Hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. The primary component is LOPERAMIDE HYDROCHLORIDE.

MedlinePlus Drug Summary

Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Loperamide is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel and by slowing down the movement of the bowel to decrease the number of bowel movements.

Related Packages: 58602-0701-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loperamide

Product Information

NDC	58602-0701
Product ID	58602-701_0ea6d174-57a9-419a-b16b-40404087d1a8
Associated GPIs	47100020100305
GCN Sequence Number	013672
GCN Sequence Number Description	loperamide HCl TABLET 2 MG ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	08550
HICL Sequence Number	001236
HICL Sequence Number Description	LOPERAMIDE HCL
Brand/Generic	Generic
Proprietary Name	Loperamide Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loperamide Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	2
Active Ingredient Units	mg/1
Substance Name	LOPERAMIDE HYDROCHLORIDE
Labeler Name	Aurohealth LLC
Pharmaceutical Class	Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA206548
Listing Certified Through	2024-12-31

Package

Package Images

NDC 58602-0701-02 (58602070102)

Pricing Information	N/A
NDC Package Code	58602-701-02
Billing NDC	58602070102
Package	2 BLISTER PACK in 1 CARTON (58602-701-02) / 6 TABLET in 1 BLISTER PACK
Marketing Start Date	2015-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f3ea8779-252e-4038-ae41-500e15c54825 Details

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

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

AUROHEALTH

NDC 58602-701-76

*Compare to the active

ingredient of Imodium® A-D

Loperamide Hydrochloride

Tablets USP 2 mg

Anti-Diarrheal

Controls the symptoms of diarrhea

24 Tablets

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE

loperamide hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-701
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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
Color	GREEN (Light Green)	Score	2 pieces
Shape	CAPSULE (Biconvex)	Size	10mm
Flavor		Imprint Code	L;28
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58602-701-01	1 in 1 CARTON	12/15/2015
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:58602-701-02	2 in 1 CARTON	12/15/2015
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:58602-701-76	4 in 1 CARTON	12/15/2015
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206548	12/15/2015

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-701) , MANUFACTURE(58602-701)

Revised: 5/2021

Document Id: 0ea6d174-57a9-419a-b16b-40404087d1a8

Set id: f3ea8779-252e-4038-ae41-500e15c54825

Version: 9

Effective Time: 20210529