Skip to Content

← See all loperamide hydrochloride brands

loperamide hydrochloride by International Laboratories, LLC

Medically reviewed on April 6, 2017

Dosage form: tablet, film coated
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: International Laboratories, LLC
NDC Code: 54458-849

International Laboratories, Inc. Loperamide Hydrochloride Tablets Drug Facts

Active ingredient (in each caplet)

Loperamide HCI 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 HCI

Do not use

if you have bloody or black stool

Ask a doctor before use if you have

• 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.‚Äč

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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 at 20º-25ºC (68º-77ºF)
  • see back panel for lot number and expiration date

Inactive ingredients

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

 1-800-579-1868

PRINCIPAL DISPLAY PANEL

Drug Facts Label

 

Drug Facts

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Imodium® A-D

Loperamide Hydrochloride Tablets, 2 mg

ANTI-DIARRHEAL

Controls the symptoms of diarrhea

14 CAPLETS*

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

Actual Size

Easy to Swallow

LIFT HERE TO OPEN

Loperamide

LOPERAMIDE HYDROCHLORIDE 
loperamide hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54458-849(NDC:59779-892)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CARNAUBA WAX 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
STARCH, PREGELATINIZED CORN 
Product Characteristics
ColorGREENScore2 pieces
ShapeCAPSULESize10mm
FlavorImprint CodeL2
Contains    
Packaging
#Item CodePackage Description
1NDC:54458-849-1414 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07523206/01/2016
Labeler - International Laboratories, LLC (023569924)
Establishment
NameAddressID/FEIOperations
International Laboratories, LLC023569924RELABEL(54458-849), REPACK(54458-849)
Establishment
NameAddressID/FEIOperations
L. Perrigo Company006013346MANUFACTURE(54458-849), RELABEL(54458-849), REPACK(54458-849)

 
International Laboratories, LLC

← See all loperamide hydrochloride brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide