LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride tablet 
Chain Drug Marketing Association Inc.

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Loperamide Hydrochloride

Drug Facts

Active ingredient (in each caplet)

Loperamide Hydrochloride 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 hydrochloride

Heart alert

Taking more than directed can cause serious heart problems or death

Do not useif you have bloody or black stool

Ask a doctor before use if you have

  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Loperamide may interact with certain prescription drugs.

When using this producttiredness, 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

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 hours
children 2-5 years
(34 to 47 lbs) 		ask a doctor
children under 2 years
(up to 33 lbs) 		do not use

Other information

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 toll-free Monday-Friday 8:30 am to 5 pm EST at 1800-406-7984.

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 Hydrochloride
Tablets USP, 2 mg

Anti-Diarrheal

Controls The Symptoms of Diarrhea

12 Caplets*

Each caplet (*capsule-shaped tablet)
contains Loperamide Hydrochloride USP, 2 mg

PRINCIPAL DISPLAY PANEL - 2 mg Caplet Blister Pack Carton
LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-338
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorgreenScore2 pieces
ShapeCAPSULESize9mm
FlavorImprint Code 123
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-338-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product02/01/1993
2NDC:63868-338-6060 in 1 BOTTLE; Type 0: Not a Combination Product02/01/1993
3NDC:63868-338-1212 in 1 BLISTER PACK; Type 0: Not a Combination Product02/01/1993
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/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(63868-338)

Revised: 1/2024
Document Id: 0ea72333-af5b-8141-e063-6294a90afe55
Set id: 237b845b-0f02-410d-9750-c95123e6142d
Version: 4
Effective Time: 20240111
 
Chain Drug Marketing Association Inc.