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Anti-Diarrheal by GREENBRIER INTERNATIONAL, INC.

Medically reviewed on Aug 17, 2017

Dosage form: tablet
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: GREENBRIER INTERNATIONAL, INC.
NDC Code: 33992-0375

Assured 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.

Heart alert: Taking more than directed can cause serious heart problems or death.

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 over2 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
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20°-25°C (68°-77°F)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

ASSURED

COMPARE TO ACTIVE INGREDIENT OF
IMODIUM® A-D*

ANTI-
DIARRHEAL

• Loperamide HCl Tablets, 2 mg
Anti-diarrheal

Controls the symptoms of diarrhea

Actual Size

24 caplets

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

1. To open, tear
at perforations and
remove a section.

2. Use ✄ to cut
through plastic
for caplet.

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Imodium® A-D.   50844      REV0417A37508

ITEM# 200900

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320

Assured 44-375

ANTI-DIARRHEAL 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0375
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
STARCH, CORN 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
SILICON DIOXIDE 
Product Characteristics
ColorGREENScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code44;375
Contains    
Packaging
#Item CodePackage Description
1NDC:33992-0375-84 BLISTER PACK in 1 CARTON
16 TABLET in 1 BLISTER PACK
2NDC:33992-0375-22 BLISTER PACK in 1 CARTON
26 TABLET in 1 BLISTER PACK
3NDC:33992-0375-41 BOTTLE in 1 CARTON
396 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/03/2005
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(33992-0375)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(33992-0375)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(33992-0375)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(33992-0375)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(33992-0375)

 
GREENBRIER INTERNATIONAL, INC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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