309 - Health A2Z Allergy Relief

309 - Health A2Z Allergy Relief

Drug Labeling and Warnings

Drug Details

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ALLERGY RELIEF- loratadine tablet 
Allegiant Health

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309 - Health A2Z Allergy Relief

Active ingredient

Loratadine 10mg

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. You may report side effects to 1-888-952-0050.

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. No 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 imprinted seal under safety cap is brokenor missing [for bottle]
  • do not use if blister unit is torn or open [for blister]

Inactive ingredients

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

Principal Display Panel

Loratadine 10mg

Loratadine 10mg

ALLERGY RELIEF 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69168-309
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize6mm
FlavorImprint Code LOR10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69168-309-081 in 1 CARTON12/16/2014
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 69168-309-091 in 1 CARTON12/16/2014
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 69168-309-301 in 1 CARTON12/16/2014
330 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 69168-309-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/16/2014
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647112/16/2014
Labeler - Allegiant Health (079501930)

Revised: 11/2018
 
Allegiant Health


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