Your browser does not support JavaScript! ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET [SAM'S WEST INC]
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RxNorm Names

ANTI DIARRHEAL (loperamide hcl) tablet
[Sam's West Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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

  •  drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • find right dose on chat. If possible, use weight to dose; otherwise, use age.
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

  • 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

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68196-375
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize10mm
FlavorImprint Code 44;375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-375-041 in 1 CARTON
1350 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/03/2005
Labeler - Sam's West Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(68196-375)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(68196-375)

Revised: 10/2013
 
Sam's West Inc

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