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NDC 49035-0520-12 Anti-Diarrheal 2 mg/1 Details

Anti-Diarrheal 2 mg/1

Anti-Diarrheal is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by EQUATE (Wal-Mart Stores, Inc.). 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: 49035-0520-12
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loperamide

Product Information

NDC	49035-0520
Product ID	49035-520_dfc14810-44d1-4336-99c2-63960e597e67
Associated GPIs	47100020100105
GCN Sequence Number	002842
GCN Sequence Number Description	loperamide HCl CAPSULE 2 MG ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	08370
HICL Sequence Number	001236
HICL Sequence Number Description	LOPERAMIDE HCL
Brand/Generic	Generic
Proprietary Name	Anti-Diarrheal
Proprietary Name Suffix	Loperamide HCl
Non-Proprietary Name	LOPERAMIDE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	2
Active Ingredient Units	mg/1
Substance Name	LOPERAMIDE HYDROCHLORIDE
Labeler Name	EQUATE (Wal-Mart Stores, Inc.)
Pharmaceutical Class	Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA021855
Listing Certified Through	n/a

Package

Package Images

NDC 49035-0520-12 (49035052012)

Pricing Information	N/A
NDC Package Code	49035-520-12
Billing NDC	49035052012
Package	1 BLISTER PACK in 1 CARTON (49035-520-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2013-01-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e16bdadf-5780-4602-bf71-7ff5a3a55959 Details

Active ingredient (in each capsule)

Loperamide HCI 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 the stool
a history of liver disease

Ask a doctor or pharmacist before use if you are

taking antibiotics.

When using this product

tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask 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 of age 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, edible ink, FD&C Blue #1 , gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

Questions or comments?

Call 1-888-287-1915

Principal Display Panel

Compare to Imodium® A-D* Active Ingredient*

Loperamide HCl

Soft Gelatin Capsules, 2 mg

Anti-Diarrheal

Controls the Symptoms of Diarrhea

Suitable for adults and children 12 years and older

SOFTGELS**

**Each Liquid-filled capsule contains 2 mg Loperamide HCl

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716

*This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor 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.

Product Label

EQUATE Anti-Diarrheal

INGREDIENTS AND APPEARANCE

ANTI-DIARRHEAL LOPERAMIDE HCL

loperamide hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-520
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
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	P13
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-520-12	1 in 1 CARTON	01/15/2013	01/05/2024
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:49035-520-48	4 in 1 CARTON	01/15/2013	01/05/2024
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:49035-520-02	120 in 1 CARTON	01/15/2013	01/05/2024
3		1 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
NDA	NDA021855	01/15/2013	01/05/2024

Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)

Revised: 10/2021

Document Id: dfc14810-44d1-4336-99c2-63960e597e67

Set id: e16bdadf-5780-4602-bf71-7ff5a3a55959

Version: 12

Effective Time: 20211020