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Anti Diarrheal by Bedrock Brands, LLC

Medically reviewed on August 25, 2016

Dosage form: tablet
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: Bedrock Brands, LLC
NDC Code: 76000-375

Di-Gel 44-375

Active ingredient (in each caplet)

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.

Do not use

if you have bloody or black stool.

Ask a doctor before use if you have
  • a 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 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 (1-800-222-1222) right away.

Directions
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
 children 9-11 years (60-95 lbs)1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs)1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs)ask a doctor

Other information
  • do not use if carton or blister unit is open or torn
  • store between 20º-25ºC (68º-77ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

Questions or comments?

Call 1-855-GODIGEL (1-855-463-4435)

Principal Display Panel

di•gel™
Anti-Diarrheal

Anti-
Diarrheal

regular
strength

Loperamide HCl 2 mg

CONTROLS THE SYMPTOMS
OF DIARRHEA

bloating & pressure
cramps

48 Caplets

actual size

di•gel™
Distributed by: di•gel Health Products, LLC.
323 W. Camden Street, Baltimore, MD 21201
1-855-GODIGEL • www.godigel.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

di•gel 44-375

ANTI DIARRHEAL 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76000-375
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
SILICON DIOXIDE 
Product Characteristics
ColorGREEN (light green) Score2 pieces
ShapeOVALSize10mm
FlavorImprint Code44;375
Contains    
Packaging
#Item CodePackage Description
1NDC:76000-375-228 BLISTER PACK in 1 CARTON
16 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/03/200507/08/2019
Labeler - Bedrock Brands, LLC (829056162)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(76000-375)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(76000-375)

 
Bedrock Brands, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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