ANTI-DIARRHEAL- loperamide tablet 
CVS Pharmacy

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CVS 44-375

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Uses

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 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

  • do not use if carton or safety seal is broken or missing

  • store between 20°-25°C (68°-77°F)

  • 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

CVS
pharmacy™

Compare to the active ingredient in Imodium® A-D†
EASY OPEN

ANTI-DIARRHEAL
LOPERAMIDE HYDROCHLORIDE TABLETS, 2 mg
CONTROLS THE SYMPTOMS OF DIARRHEA

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

24 CAPLETS*
*Each caplet (capsule-shaped tablets) contains 2 mg loperamide hydrochloride

Easy to swallow

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Imodium® A-D.
50844    REV1212D37508

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2013 CVS/pharmacy
www.cvs.com    1-800-shop-CVS

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

CVS 44-375

CVS 44-375

ANTI-DIARRHEAL 
loperamide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-375
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorGREENScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-375-022 in 1 CARTON05/03/200511/30/2018
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:59779-375-228 in 1 CARTON05/03/200511/30/2018
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:59779-375-084 in 1 CARTON05/03/200511/30/2018
36 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:59779-375-443 in 1 CARTON05/03/200511/30/2018
46 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:59779-375-061 in 1 CARTON05/03/200511/30/2018
5200 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:59779-375-461 in 1 CARTON05/03/200511/30/2018
696 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/03/200511/30/2018
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(59779-375)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(59779-375)

Revised: 9/2016
 
CVS Pharmacy