Loperamide Hydrochloride by Cintas Corporation / OHM LABORATORIES INC. Loperamide Hydrochloride

Loperamide Hydrochloride by

Drug Labeling and Warnings

Loperamide Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation, OHM LABORATORIES INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride tablet 
Cintas Corporation

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

Distributed by
Cintas Corporation, Mason, OH 45040

PRINCIPAL DISPLAY PANEL - 2 mg Caplet Blister Pack Carton

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

ZEE®

Loperamide Hydrochloride
Tablets USP, 2 mg

Anti-Diarrheal

See New Warnings
and Directions

12 Caplets*

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

Controls the Symptoms
of Diarrhea

LH-boxlabel

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42961-048
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
ShapeCAPSULE (shaped tablet) Size9mm
FlavorImprint Code 123
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42961-048-022 in 1 BOX01/07/2021
16 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07409101/07/202108/30/2022
Labeler - Cintas Corporation (056481716)
Registrant - Cintas Corporation (056481716)
Establishment
NameAddressID/FEIBusiness Operations
OHM LABORATORIES INC.051565745manufacture(42961-048)

Revised: 8/2022
Document Id: 58ffc4f8-32a5-400d-858d-59a8e90066d7
Set id: 1a3aa813-48a5-433b-bfe4-3c89bb5f51bd
Version: 2
Effective Time: 20220830
 
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