ANTI-DIARRHEAL- loperamide hydrochloride tablet 
SUPERVALU INC.

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Active ingredients

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 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 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

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

Principal Display Panel

equaline®

compare to Imodium® A-D

active ingredient†

NDC 41163-375-02

loperamide hydrchloride tablets, 2 mg

anti-diarrheal tablets

• controls the symptoms of diarrhea

12 caplets*

*each caplet (capsule shaped tablet) contains 2 mg loperamide hydrochloride

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

50844    ORG071037502

DISTRIBUTED BY SUPERVALU INC.

EDEN PRARIE, MN 55344

375-02

ANTI-DIARRHEAL 
loperamides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-375
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorGREENScore2 pieces
ShapeCAPSULESize10mm
FlavorImprint Code 44;375
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-375-081 in 1 CARTON
124 in 1 BLISTER PACK
2NDC:41163-375-221 in 1 CARTON
248 in 1 BLISTER PACK
3NDC:41163-375-021 in 1 CARTON
312 in 1 BLISTER PACK
4NDC:41163-375-461 in 1 CARTON
496 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/03/2005
Labeler - SUPERVALU INC. (006961411)

Revised: 08/2011
Document Id: 2e1ba21b-ed4c-4cb8-a307-0e72b5754582
Set id: f16e07f3-0efb-4451-adbb-e427f9abc7ae
Version: 2
Effective Time: 20110817
 
SUPERVALU INC.