ALLERGY- loratadine tablet 
Selder, S.A. de C.V.

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309 - XL-3 Allergy

Active ingredient

Loratadine 10mg

Purpose

Antihistamine

Uses

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

■ sneezing

■ runny nose

■ 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

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. 

Pregnancy/Breastfeeding

 If pregnant or breast-feeding, ask a health professional before use. 

Keep out of reach of children

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

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° to 25°C (68° to 77° F)

■ protect from excessive moisture

■ do not use if blister packaging is torn or open

Inactive ingredients

croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

1-888-952-0050 Monday through Friday 9 AM - 5 PM EST

Principal Display Panel

XL-3 Allergy Relief

XL-3 Allergy Relief

 

ALLERGY 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-309
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize6mm
FlavorImprint Code LOR;10;APO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63654-309-101 in 1 CARTON12/16/2014
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647112/16/2014
Labeler - Selder, S.A. de C.V. (824413629)

Revised: 12/2016
Document Id: 39201d37-e750-420b-8035-feb97bc77c21
Set id: afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251
Version: 4
Effective Time: 20161222
 
Selder, S.A. de C.V.