Your browser does not support JavaScript! LORATADINE TABLET [PUBLIX SUPER MARKETS INC]
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RxNorm Names

LORATADINE tablet
[Publix Super Markets 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

PRINCIPAL DISPLAY PANEL

Publix

24 - HOUR

allergy relief

LORATADINE TABLETS USP, 10 mg

ANTIHISTAMINE

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy throat or nose

10 TABLETS

NON-DROWSY*

*When taken as directed.

See Drug Facts Panel.

**Compare to Active Ingredient in Claritin®

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

5084017/0211

This is the 10 count blister carton label for Publix Loratadine tablets, USP 10 mg.
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-526
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:56062-526-6910 in 1 BLISTER PACK
2NDC:56062-526-3130 in 1 BLISTER PACK
3NDC:56062-526-9060 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613408/19/2003
Labeler - Publix Super Markets Inc (006922009)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(56062-526)

Revised: 12/2012
Document Id: fba0b636-da83-40bc-8b42-cac904d65edd
Set id: af62d327-791f-48c1-9200-d49b71558885
Version: 1
Effective Time: 20121227
 
Publix Super Markets Inc

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