ANTI-DIARRHEAL- loperamide hcl tablet

Anti-Diarrheal by

Drug Labeling and Warnings

Anti-Diarrheal by is a Otc medication manufactured, distributed, or labeled by GREAT LAKES WHOLESALE, MARKETING, & SALES, INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

• store between 20º-25ºC (68º-77ºF)
  
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 
• 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

HEALTHCARE™

NDC: 64092-105-12

Compare to the
active ingredient in
Imodium® A-D*

Anti-Diarrheal
Loperamide HCl Tablets, 2 mg
Anti-diarrheal

Controls the Symptoms of Diarrhea

Actual Size

12 CAPLETS

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Imodium® A-D.
50844    REV0417L37502

1. To open, tear at perforations and remove a section.
2. Use scissors to cut through plastic for caplet.

HEALTHCARE GUARANTEE
If you are not completely satisfied with this product, regardless of reason, return your unused portion to Great Lakes Wholesale for a full refund

Distributed by: Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave. S.E., Grand Rapids, MI 49512
www.glwholesale.com

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

HealthCare 44-375

INGREDIENTS AND APPEARANCE

ANTI-DIARRHEAL 
loperamide hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64092-105
Route of Administration	ORAL

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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)

Product Characteristics
Color	GREEN	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	44;375
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64092-105-12	2 in 1 CARTON	05/03/2005
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 - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(64092-105)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(64092-105)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(64092-105)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(64092-105)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(64092-105)