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Loperamide Hydrochloride by Chain Drug Marketing Association Inc.

Medically reviewed on Jun 1, 2018

Dosage form: tablet
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: Chain Drug Marketing Association Inc.
NDC Code: 63868-338

Loperamide Hydrochloride

Drug Facts

Active ingredient (in each caplet)

Loperamide HCl 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 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
  • 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 (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 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; 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
children 2-5 years (34 to 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)
  • 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 aluminum lake, FD&C blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions?

call 1-800-406-7984

Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995

PRINCIPAL DISPLAY PANEL - 2 mg Caplet Blister Pack Carton

QUALITY®
CHOICE

NDC 63868-338-12

*Compare to
Active Ingredient in
IMODIUM®A-D

See New Warnings and Directions

Loperamide HCl Tablets
USP, 2 mg

Anti-Diarrheal

Controls The Symptoms of Diarrhea

12 Caplets*
Each caplet (*capsule-shaped tablet)
contains Loperamide HCl USP, 2 mg

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-338
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 (15 MPA.S AT 5%) 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GLYCERYL TRISTEARATE 
MAGNESIUM STEARATE 
POWDERED CELLULOSE 
STARCH, CORN 
Product Characteristics
ColorgreenScore2 pieces
ShapeCAPSULESize9mm
FlavorImprint Code123
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-338-2424 TABLET in 1 BLISTER PACK
2NDC:63868-338-6060 TABLET in 1 BOTTLE
3NDC:63868-338-1212 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07409102/01/1993
Labeler - Chain Drug Marketing Association Inc. (011920774)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.051565745manufacture(63868-338)

 
Chain Drug Marketing Association Inc.

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Further information

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

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