HEB 44-375

HEB 44-375

Drug Labeling and Warnings

Drug Details

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ANTI-DIARRHEAL- loperamide hcl tablet 
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HEB 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
  • a history of abnormal heart rhythm 

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Loperamide may interact with certain prescription drugs.

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 2-5 years (34-47 lbs)ask a doctor
children under 2 years (up to 33 lbs)do not use

Other information

  • store between 20°-25°C (68°-77°F)
  • 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 or comments?

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

Principal Display Panel

Compare to Imodium® A-D active ingredient*

NDC: 37808-375-02

H-E-B®

Anti-
Diarrheal

Loperamide Hydrochloride 2 mg
Anti-Diarrheal

Diarrhea Relief

Controls The Symptoms of Diarrhea,
Including Travelers’ Diarrhea

24 CAPLETS
Each caplet contains 2 mg loperamide hydrochloride

actual
size

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

2. Use ✄ to cut
through plastic
for caplet.

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    REV0619A37508    

MADE WITH PRIDE AND CARE FOR
H-E-B®, SAN ANTONIO, TX 78204

H-E-B®
100%
GUARANTEE
promise
If you aren't completely pleased
with this product, we'll be happy to
replace it or refund your money.
You have our word on it.

44-375

44-375

ANTI-DIARRHEAL 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37808-375
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
ColorGREENScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37808-375-022 in 1 CARTON05/03/2005
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 37808-375-084 in 1 CARTON05/03/2005
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 37808-375-221 in 1 CARTON05/03/200504/30/2020
348 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/03/2005
Labeler - H E B (007924756)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(37808-375)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(37808-375)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(37808-375)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(37808-375)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(37808-375)

Revised: 1/2020
 
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