Loratadine Orally Disintegrating Tablets USP 10 mg

Loratadine Orally Disintegrating Tablets USP 10 mg

Drug Labeling and Warnings

Drug Details

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LORATADINE ODT - loratadine tablet, orally disintegrating 
WALGREEN CO.

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Loratadine Orally Disintegrating Tablets USP 10 mg

Drug Facts

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
  • sneezing
  • itchy, watery eyes
  • 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 (1-800-222-1222) right away.

Directions


  • place 1 tablet on tongue; tablet disintegrates, with or without water 

 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

  • Phenylketonurics: Contains phenylalanine 2.25 mg per tablet
  • do not use if the individual blister unit is open or torn
  • store at 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister
  • Complies with USP test 2 for Disintegration

Inactive ingredients

aspartame, crospovidone, mannitol, microcrystalline cellulose,  peppermint, pregelatinized starch (maize), sodium stearyl fumarate

Questions or comments?

call 1-855-274-4122

DISTRIBUTED BY:
 WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

Walgreens
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MADE IN INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 x 10) Orally Disintegrating Tablets

NEW Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDED
NDC: 0363-9937-84
NON-DROWSY*
ORIGINAL PRESCRIPTION STRENGTH
wal-itin
Loratadine Orally Disintegrating
Tablets USP 10 mg /
Antihistamine

  • Relief of runny nose, sneezing, itchy throat or nose & itchy, watery eyes
  • No water needed — melts in your mouth

INDOOR &
OUTDOOR
ALLERGIES

24 HOUR

Compare to Claritin® RediTabs®

active ingredient‡‡


                
ORALLY DISINTEGRATING TABLETS
*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 x 10) Orally Disintegrating Tablets





LORATADINE ODT 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0363-9937
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PEPPERMINT (UNII: V95R5KMY2B)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeROUND (Biconvex) Size8mm
FlavorPEPPERMINTImprint Code K;9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0363-9937-843 in 1 CARTON04/11/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20847704/11/2018
Labeler - WALGREEN CO. (008965063)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(0363-9937) , MANUFACTURE(0363-9937)

Revised: 10/2019
 
WALGREEN CO.


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