Your browser does not support JavaScript! LORATADINE TABLET [MEDLINE INDUSTRIES, INC.]
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RxNorm Names

LORATADINE tablet
[Medline Industries, 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 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

  • 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-MEDLINE (633-5463), Monday - Friday, 9AM - 5PM CST

PRINCIPAL DISPLAY PANEL

MEDLINE

NDC 53329-651-33

Compare to the active ingredient in Claritin®

NON-DROWSY*

LORATADINE TABLETS, USP 10 mg

ANTIHISTAMINE

ALLERGY RELIEF

Indoor & Outdoor Allergies

24 HOUR RELIEF of:

Sneezing

Runny Nose

Itchy, Watery Eyes

• Itchy Throat or Nose

10 mg

30 Tablets

(When taken as directed. See Drug Facts Panel.)

Distributed by: Medline, Industries, Inc.

5099016/1012

30's bottle label
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53329-651
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:53329-651-3330 in 1 BOTTLE
2NDC:53329-651-3890 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613408/19/2003
Labeler - Medline Industries, Inc. (025460908)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(53329-651)

Revised: 3/2013
 
Medline Industries, Inc.

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