LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride tablet 
Medline Industries, LP

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664 Loperamide Hydrochloride

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 HCI
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
  • a history of abnormal heart rhythm

Ask a doctor or pharmacist before use if

you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

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 (1-800-222-1222) right away.

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; 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 2-5 years

(34-47 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 or comments?

Call toll free 1-800-MEDLINE (633-5463)
Monday-Friday 9AM-5PM CST

Manufacturing Information

Packaged for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Packaged in USA with domestic and foreign materials
www.medline.com
1-800-MEDLINE (633-5463)
REF: OTCS0801C2
V1 RG22OHM

Package Label

V1 RG22OHM

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-664
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 (UNII: 68401960MK)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TRISTEARIN (UNII: P6OCJ2551R)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorgreenScore2 pieces
ShapeCAPSULESize9mm
FlavorImprint Code 123
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-664-5712 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 - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc184769029manufacture(53329-664)

Revised: 12/2024
Document Id: 2a761ab3-5c74-92c0-e063-6294a90a93aa
Set id: 03d68bcf-6413-4fe3-8263-39cc315452d2
Version: 8
Effective Time: 20241229
 
Medline Industries, LP