ANTI DIARRHEAL- loperamide hydrochloride tablet 
Bedrock Brands, LLC

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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

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

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

di•gel 44-375

ANTI DIARRHEAL 
loperamide hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76000-375
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 44;375
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76000-375-22 8 in 1 CARTON
1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076497 05/03/2005
Labeler - Bedrock Brands, LLC (829056162)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(76000-375)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(76000-375)

Revised: 9/2015
Document Id: f17c7834-947f-4bd8-bca3-ffea0f04bb78
Set id: ca42762d-34be-4b55-b59f-c3b537d790b0
Version: 2
Effective Time: 20150916
 
Bedrock Brands, LLC