Your browser does not support JavaScript! LEADER LORATADINE (LORATADINE) TABLET [CARDINAL HEALTH]
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RxNorm Names

LEADER LORATADINE (loratadine) tablet
[Cardinal Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

ACTIVE INGREDIENT (IN EACH TABLET)

Loratadine USP, 10 mg

PURPOSE

Antihistamine

USES

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

WARNINGS

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

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.

DIRECTIONS

adults and children 6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours

children under 6 years of age: ask a doctor

consumers with liver or kidney disease: ask a doctor

OTHER INFORMATION

  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20 and 25° C (68 and 77° F)
  • protect from excessive moisture

INACTIVE INGREDIENTS

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

NDC 37205-346-52

LEADER®

Compare to Claritin®active ingredient

Non-Drowsy*

ORIGINAL PRESCRIPTION STRENGTH

Loratadine

Loratadine Tablets USP, 10 mg/Antihistamine

Indoor & Outdoor Allergies

24 Hour Allergy Relief

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

10 TABLETS

Thisproduct is not manufactured or distributed by Schering-Plough HealthCare Products, Inc.,owner of theregisteredtrademarkClaritin®.

This is the 10 count blister carton label for Leader Loratadine tablets USP, 10 mg.

10's Blister Carton

This is the 90 count bottle carton label for Leader Loratadine tablets USP, 10 mg.

90's Bottle Carton

LEADER LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-346
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
STARCH, PREGELATINIZED CORN 
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code RX526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-346-5210 in 1 BLISTER PACK
2NDC:37205-346-6020 in 1 BLISTER PACK
3NDC:37205-346-6530 in 1 BLISTER PACK
4NDC:37205-346-7260 in 1 BOTTLE
5NDC:37205-346-7590 in 1 BOTTLE
6NDC:37205-346-47150 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613408/19/2003
Labeler - Cardinal Health (097537435)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(37205-346)

Revised: 3/2012
 
Cardinal Health

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