WELMATE ANTI DIARRHEAL LOPERAMIDE HCL SOFTGELS- loperamide hydrochloride capsule 
YYBA CORP

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WELMATE Anti-Diarrheal (Loperamide HCl) Softgels

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

Other information

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:

Label2

WELMATE ANTI DIARRHEAL LOPERAMIDE HCL SOFTGELS 
loperamide hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScoreno score
ShapeOVALSize9mm
FlavorImprint Code LP2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73581-102-242 in 1 CARTON08/22/2020
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02185508/22/2020
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
 
YYBA CORP