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NDC 70000-0461-01 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 CARDINAL HEALTH. 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: 70000-0461-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loperamide

Product Information

NDC	70000-0461
Product ID	70000-0461_df632120-a1f3-1513-e053-2a95a90a9bfd
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	n/a
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	CARDINAL HEALTH
Pharmaceutical Class	Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA021855
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0461-01 (70000046101)

Pricing Information
NDC Package Code	70000-0461-1
Billing NDC	70000046101
Package	2 BLISTER PACK in 1 CARTON (70000-0461-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2019-01-21
NDC Exclude Flag	N
Price Per Unit	0.14999
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ANTI-DIARRHEAL 2 MG SOFTGEL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 6
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL bd58d6e9-628c-4c6b-b44c-da95e0417ba7 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
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 capsules after the first loose stool; 1 capsule after each subsequent loose stool; but no more than 4 capsules 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 toll free 1-888-235-2466

SPL UNCLASSIFIED SECTION

CardinalHealth TM

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

All LEADER TM Brand Products Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied.

†This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Imodium ® A-D.

CARDINAL HEALTH, the Cardinal Health LOGO,

LEADER, and the Leader LOGO are trademarks or

registered trademarks of Cardinal Health. All other

marks are the property of their respective owners.

Manufactured for:

BIONPHARMA

600 Alexander Road,

Princeton, NJ 08540

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.

L0000566

Lot#

Expiration Date

R03/22

Principal Display Panel

LEADER TM

NDC 70000-0461-1

Anti-Diarrheal

Loperamide Hydrochloride Capsules, 2 mg

Controls the Symptoms of Diarrhea

Suitable for Adults and Children

12 years and over

24 SOFTGELS*

*Each Liquid-Filled Capsule

Contains 2 mg Loperamide HCl

Actual Size

COMPARE TO

IMODIUM ® A-D

active ingredient †

100 % Money Back Guarantee

INGREDIENTS AND APPEARANCE

ANTI-DIARRHEAL

loperamide hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0461
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 CAPRYLATE (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	LP2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0461-1	2 in 1 CARTON	01/21/2019
1		12 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	01/21/2019

Labeler - CARDINAL HEALTH (063997360)

Registrant - Bionpharma Inc. (079637826)

Name	Address	ID/FEI	Business Operations
Establishment
Patheon Softgels Inc.		002193829	manufacture(70000-0461)

Revised: 5/2022

Document Id: df632120-a1f3-1513-e053-2a95a90a9bfd

Set id: bd58d6e9-628c-4c6b-b44c-da95e0417ba7

Version: 3

Effective Time: 20220519