ANTI DIARRHEAL- loperamide hydrochloride tablet 
Sam's West Inc

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Simply Right 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 reactions to loperamide HCl.

Do not use

if you have bloody or black stool

Ask a doctor before use if you have

  • high 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 buldging. 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 older  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 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 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

NDC 68196-375-04

SIMPLY RIGHT
Health Care

Loperamide Hydrochloride caplets, 2 mg
anti-diarrheal

Compare to Imodium A-D® active ingredient*

controls the symptoms of diarrhea
easy to swallow, small caplets

Each caplet (capsule-shaped tablets) contains2 mg Loperamide Hydrochloride

350 caplets

*This product is not manufactured or distributed by McNeil consumer Healthcare, owner of the registered trademark Imdium A-D®.
50844        REV1212A37504

Distributed by:
SAM'S West, Inc.
Bentonville, AR 72716

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Simply Right 44-375

Simply Right 44-375

ANTI DIARRHEAL 
loperamide hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-375
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)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code 44;375
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68196-375-04 1 in 1 CARTON
1 350 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076497 05/03/2005
Labeler - Sam's West Inc (051957769)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(68196-375)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(68196-375)

Revised: 10/2013
Document Id: f43b3f3d-731f-4011-87f2-5c1e4f3e648a
Set id: a55e476a-b821-46bc-bde7-56a7963b8ee5
Version: 2
Effective Time: 20131011
 
Sam's West Inc