Winco 44-375

Winco 44-375

Drug Labeling and Warnings

Drug Details

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ANTI-DIARRHEAL- loperamide hcl tablet 
WinCo Foods, LLC

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Winco 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 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?

Call 1-800-824-1706 Monday-Friday 9am - 4pm MST

Principal Display Panel

†Compare to the active ingredient in IMODIUM® A-D

Winco®
FOODS

Anti-Diarrheal
LOPERAMIDE HCl TABLETS/
ANTI-DIARRHEAL
Controls the Symptoms of Diarrhea

12
Caplets*

*Capsule-Shaped Tablets

Winco 44-375

Winco 44-375

ANTI-DIARRHEAL 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67091-335
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)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorGREENScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67091-335-182 in 1 CARTON02/08/2019
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649702/08/2019
Labeler - WinCo Foods, LLC (056098817)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(67091-335)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(67091-335)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(67091-335)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(67091-335)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(67091-335)

Revised: 12/2018
 
WinCo Foods, LLC


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