ANTI-DIARRHEAL- loperamide hcl tablet 
Sam's West Inc

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Members Mark 44-375 Delisted

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 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

  • do not use if carton or safety seal is broken or missing
  • 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 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

Compare to Imodium® A-D
active ingredient*

NDC 68196-975-98

Member's Mark®
QUALITY GUARANTEED

anti-diarrheal
loperamide HCl
2 mg
anti-diarrheal

• Controls the symptoms
of diarrhea

• Easy-to-swallow,
small caplets

actual size

400
Caplets

2x200
Count Bottles

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

*This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark
Imodium® A-D.                              50844      ORG121237506

100% MONEY BACK GUARANTEE
SUPERIOR QUALITY AND PERFORMANCE
We would like to hear from you with any comments or suggestions.
In the continental U.S. or Canada, you can call us at 1.800.426.9391 from
8:30 a.m. to 4:00 p.m. ET Monday - Friday.

DISTRIBUTED BY:
SAM'S WEST, INC.
BENTONVILLE, AR 72716

Members Mark 44-375

Members Mark 44-375

ANTI-DIARRHEAL 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-975
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
ColorGREEN (light green) Score2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-975-982 in 1 CARTON05/03/200504/04/2020
1200 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/03/200504/04/2020
Labeler - Sam's West Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(68196-975)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(68196-975)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(68196-975)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(68196-975)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(68196-975)

Revised: 5/2020
Document Id: dbbccaff-5b50-46e6-8716-d501a188679c
Set id: b81c7709-65ce-46ac-949f-cbb4e3182b19
Version: 9
Effective Time: 20200504
 
Sam's West Inc