ANTI-DIARRHEAL- loperamide hcl tablet 
Chain Drug Consortium

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Premier Value 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 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

  • 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
  • store between 20º-25ºC ( 68º-77ºF)

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

Premier
Value®

*COMPARE TO THE ACTIVE INGREDIENT
IN IMODIUM® A-D

Anti-diarrheal
Loperamide HCl Tablets, 2 mg
ANTI-DIARRHEAL

Controls the symptoms
of diarrhea

24 Caplets

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

*This product is not manufactured or distributed by
McNeil Consumer Healthcare, owner of the registered
trademark Imodium® A-D.     50844          REV0715A37508

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087

If for any reason you are not satisfied with
this product, please return it to the store
where purchased for a full refund.
Premier Value 44-375

Premier Value 44-375


ANTI-DIARRHEAL 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-638
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorGREEN (light) Score2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-638-183 in 1 CARTON05/03/200507/10/2020
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:68016-638-061 in 1 CARTON05/03/200507/10/2020
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:68016-638-244 in 1 CARTON05/03/200507/10/2020
36 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/03/200507/10/2020
Labeler - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(68016-638)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(68016-638)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(68016-638)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(68016-638)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(68016-638)

Revised: 7/2018
 
Chain Drug Consortium