Your browser does not support JavaScript! LORATADINE TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]
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LORATADINE tablet
[Chain Drug Marketing Association Inc.]


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 over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

OTHER INFORMATION

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

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

QC QUALITY CHOICE®

NDC 63868-151-30

*Compare to the active ingredient of Claritin®

NON-DROWSY٭

Allergy Relief

Loratadine Tablets USP, 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

Sneezing; Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

30 Tablets

24 Hour

Allergy Relief

٭When taken as directed. See Drug Facts Panel.

©DISTRIBUTED BY QUALITY CHOICE

50693580908

This is the 30 count blister carton label for Quality Choice Loratadine tablets USP, 10 mg.

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-151
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 Description
1NDC:63868-151-1010 in 1 BLISTER PACK
2NDC:63868-151-3030 in 1 BLISTER PACK
3NDC:63868-151-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613408/19/2003
Labeler - Chain Drug Marketing Association Inc. (011920774)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(63868-151)

Revised: 09/2012
Document Id: 4d81a3ac-7d56-4d16-b0d6-32c1122004e3
Set id: b4edf5b1-398d-405a-8a42-76044b31ebb7
Version: 1
Effective Time: 20120913
 
Chain Drug Marketing Association Inc.

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