309 - Health A2z Allergy Relief

309 - Health A2z Allergy Relief
SPL v6
SPL
SPL Set ID 0991388a-2eb8-4913-9efc-adf411eddf3a
Route
ORAL
Published
Effective Date 2018-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline

Identifiers & Packaging

Pill Appearance
Imprint: LOR10 Shape: oval Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2014-12-16 Until 2024-12-04

Description

Loratadine 10mg

Purpose

 Antihistamine


Medication Information

Purpose

 Antihistamine

Description

Loratadine 10mg

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 


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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients

Active Ingredient

Loratadine 10mg

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 

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel
Allergy Relief
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.

Keep Out of Reach of Children

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

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.


Structured Label Content

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 


Purpose

 Antihistamine

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

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients

Active Ingredient (Active ingredient)

Loratadine 10mg

Other Information (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 (Inactive ingredients)

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

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel
Allergy Relief
When Using This Product (When using this product)

do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor (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.

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease. Your doctor should determine if you need a different dose.


Advanced Ingredient Data


Raw Label Data

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