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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

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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