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Loperamide Hydrochloride by Medline Industries, Inc.

Medically reviewed on December 29, 2017

Dosage form: tablet
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: Medline Industries, Inc.
NDC Code: 53329-664

Drug Facts

ACTIVE INGREDIENT (IN EACH CAPLET)

Loperamide HCI USP, 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
  • diarrhea lasts for more than 2 days
  • symptoms get worse
  • 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 (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;
    ½ 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;
    ½ 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 side panel for lot number and expiration date
  • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

INACTIVE INGREDIENTS

Anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

QUESTIONS?

Call 1-800-MEDLINE (633-5463)

PRINCIPAL DISPLAY PANEL

MEDLINE

NDC 53329-664-57

Compare to the active ingredient in Imodium®A-D

LOPERAMIDE HCl TABLETS USP, 2 mg

ANTI-DIARRHEAL

Controls The Symptoms of Diarrhea

2 mg

12 Caplets *

Each Caplet ( *capsule-shaped tablet)

contains Loperamide HCl USP, 2 mg

Distributed by: Medline Industries, Inc.

5099015/1012

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-664
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
TRISTEARIN 
MAGNESIUM STEARATE 
POWDERED CELLULOSE 
STARCH, PREGELATINIZED CORN 
Product Characteristics
ColorgreenScore2 pieces
ShapeCAPSULESize9mm
FlavorImprint Code123
Contains    
Packaging
#Item CodePackage Description
1NDC:53329-664-5712 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07409102/01/1993
Labeler - Medline Industries, Inc. (025460908)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.184769029manufacture(53329-664)

 
Medline Industries, Inc.

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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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