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Loperamide Hydrochloride by Zee Medical Inc

Medically reviewed on May 31, 2018

Dosage form: tablet
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: Zee Medical Inc
NDC Code: 35418-123

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 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
  • 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
ZEE MEDICAL, INC., Irvine, CA 92606

PRINCIPAL DISPLAY PANEL - 2 mg Caplet Blister Pack Carton

COMPARE TO THE
ACTIVE INGREDIENT IN
IMODIUM® A-D**

ZEE®

Loperamide HCl Tablets USP, 2 mg

Anti-Diarrheal

See New Warnings
and Directions

12 Caplets*

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

Controls the Symptoms
of Diarrhea

1457

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-123
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 
CORN OIL 
MAGNESIUM STEARATE 
POWDERED CELLULOSE 
STARCH, CORN 
Product Characteristics
ColorgreenScore2 pieces
ShapeCAPSULE (shaped tablet) Size9mm
FlavorImprint Code123
Contains    
Packaging
#Item CodePackage Description
1NDC:35418-123-122 BLISTER PACK in 1 CARTON
16 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07409101/16/2014
Labeler - Zee Medical Inc (009645623)
Registrant - Ranbaxy Pharmaceuticals Inc (937890044)
Establishment
NameAddressID/FEIOperations
OHM LABORATORIES INC.051565745manufacture(35418-123)

 
Zee Medical Inc

← See all Loperamide Hydrochloride brands

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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