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NDC 69452-0176-12 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 Bionpharma 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: 69452-0176-12
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loperamide

Product Information

NDC	69452-0176
Product ID	69452-176_a3d76812-4130-4578-a272-e165f67d9238
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	Bionpharma Inc.
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 69452-0176-12 (69452017612)

Pricing Information	N/A
NDC Package Code	69452-176-12
Billing NDC	69452017612
Package	1 BLISTER PACK in 1 CARTON (69452-176-12) / 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2019-08-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8f1ee652-a4f7-4e5b-874f-46aa641cd43f 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 capsules 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 (Mon - Fri 9AM - 5PM EST)

†This product is not manufactured or distributed by the 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.

Distributed by:

BIONPHARMA

600 Alexander Road,

Princeton, NJ 08540

L0000182

Rev # 05/19

Principal Display Panel

NDC 69452-176-12

Be Health

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

LOPERAMIDE HCl CAPSULES, 2 mg

Anti-Diarrheal

Controls the Symptoms of Diarrhea

Suitable for Adults and Children 12 Years and Over

24 Softgels*

*soft gelatin liquid-filled capsules

each softgel contains 2 mg loperamide HCl

INGREDIENTS AND APPEARANCE

ANTI-DIARRHEAL

loperamide hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69452-176
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:69452-176-12	1 in 1 CARTON	08/02/2019
1		24 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	08/02/2019

Labeler - Bionpharma Inc. (079637826)

Registrant - Bionpharma Inc. (079637826)

Name	Address	ID/FEI	Business Operations
Establishment
Patheon Softgels Inc.		002193829	manufacture(69452-176)

Revised: 9/2019

Document Id: a3d76812-4130-4578-a272-e165f67d9238

Set id: 8f1ee652-a4f7-4e5b-874f-46aa641cd43f

Version: 1

Effective Time: 20190909