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NDC 73581-0102-24 WELMATE Anti Diarrheal Loperamide HCl Softgels 2 mg/1 Details

WELMATE Anti Diarrheal Loperamide HCl Softgels 2 mg/1

WELMATE Anti Diarrheal Loperamide HCl Softgels is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by YYBA CORP. 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: 73581-0102-24
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loperamide

Product Information

NDC	73581-0102
Product ID	73581-102_ec6b87f1-e600-21c2-e053-2a95a90ab76d
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	WELMATE Anti Diarrheal Loperamide HCl Softgels
Proprietary Name Suffix	n/a
Non-Proprietary Name	LOPERAMIDE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	2
Active Ingredient Units	mg/1
Substance Name	LOPERAMIDE HYDROCHLORIDE
Labeler Name	YYBA CORP
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 73581-0102-24 (73581010224)

Pricing Information	N/A
NDC Package Code	73581-102-24
Billing NDC	73581010224
Package	2 BLISTER PACK in 1 CARTON (73581-102-24) / 12 CAPSULE in 1 BLISTER PACK
Marketing Start Date	2020-08-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ae2e15e9-1707-296d-e053-2995a90a1b95 Details

Drug Facts

Active ingredient (in each softgel)

Loperamide HCl 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 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 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
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

do not use if blister unit is torn or open
store at 20°- 25°C (68° - 77°F)

Inactive ingredients

butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water.

Questions?

call toll-free 1-800-935-6737

Package Labeling:

INGREDIENTS AND APPEARANCE

WELMATE ANTI DIARRHEAL LOPERAMIDE HCL SOFTGELS

loperamide hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73581-102
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	OVAL	Size	9mm
Flavor		Imprint Code	LP2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73581-102-24	2 in 1 CARTON	08/22/2020
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	08/22/2020

Labeler - YYBA CORP (006339772)

Revised: 11/2022

Document Id: ec6b87f1-e600-21c2-e053-2a95a90ab76d

Set id: ae2e15e9-1707-296d-e053-2995a90a1b95

Version: 3

Effective Time: 20221101