ANTI-DIARRHEAL- loperamide hcl tablet 
FRED'S, INC.

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Freds Pharmacy 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.
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 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

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • 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, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

NDC 55315-975-08

fred's
Pharmacy

COMPARE TO THE
ACTIVE INGREDIENT in

IMODIUM® A-D*

Anti-
Diarrheal

Loperamide HCl, 2 mg

Anti-Diarrheal

Controls The Symptoms
of Diarrhea

24 CAPLETS

Actual Size

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
Johnson & Johnson Corporation, owner of the registered
trademark Imodium® A-D.    50844          ORG041737508

DISTRIBUTED BY: fred's, Inc.
4300 GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100% satisfaction
guaranteed

1. To open, tear
at perforations and
remove a section.

2. Use scissors to cut
through plastic
for caplet.

freds pharmacy 44-375

freds pharmacy 44-375

ANTI-DIARRHEAL 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-975
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)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
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:55315-975-084 in 1 CARTON05/01/201912/31/2021
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/01/201912/31/2021
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55315-975)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55315-975)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(55315-975)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(55315-975)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(55315-975)

Revised: 6/2020
 
FRED'S, INC.