Alavert ®

Alavert ®
SPL v2
SPL
SPL Set ID 1704474a-9b99-de45-e063-6294a90ac59b
Route
ORAL
Published
Effective Date 2024-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Aspartame Pullulan Polysorbate 80 Mannitol

Identifiers & Packaging

Pill Appearance
Imprint: C24 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
ANDA Active Since 2024-10-31

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

When using this product do not use more than directed. Taking more than recommended may cause drowsiness.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Section 53414-9

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

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 0.56 mg per tablet
  • safety sealed: do not use if the individual blister unit imprinted with Alavert® Citrus Burst is open or torn
  • store at 20-25°C (68-77°F)
  • use tablet immediately after opening individual blister
  • complies with USP procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration
Inactive Ingredients

anhydrous citric acid, aspartame, flavors, mannitol, polysorbate 80, pullulan

Questions Or Comments?

Call 1-800 ALAVERT (1-800-252-8378) weekdays 9 AM to 5 PM EST

Active Ingredient (in Each Tablet)

Loratadine 10 mg

Principal Display Panel 60 Tablet Blister Pack Carton

NEW FORMULA

Compare to the active ingredient in Claritin ® RediTabs ® Original Prescription Strength †

NON-DROWSY*

ALLERGY RELIEF

ALAVERT ®

Loratadine Orally Disintegrating Tablet USP, 10 mg

Antihistamine

Indoor/Outdoor

ALLERGIES

24 Hour Relief of

Sneezing, Runny Nose

Itchy/Watery Eyes

Itchy Throat or Nose

Melts In Your Mouth

CITRUS BURST Flavor

*When taken as directed. See Drug Facts Panel.

VALUE SIZE 60 Orally Disintegrating Tablets


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

When using this product do not use more than directed. Taking more than recommended may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

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 (Other information)
  • phenylketonurics: contains phenylalanine 0.56 mg per tablet
  • safety sealed: do not use if the individual blister unit imprinted with Alavert® Citrus Burst is open or torn
  • store at 20-25°C (68-77°F)
  • use tablet immediately after opening individual blister
  • complies with USP procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, aspartame, flavors, mannitol, polysorbate 80, pullulan

Questions Or Comments? (Questions or comments?)

Call 1-800 ALAVERT (1-800-252-8378) weekdays 9 AM to 5 PM EST

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Loratadine 10 mg

Principal Display Panel 60 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 60 Tablet Blister Pack Carton)

NEW FORMULA

Compare to the active ingredient in Claritin ® RediTabs ® Original Prescription Strength †

NON-DROWSY*

ALLERGY RELIEF

ALAVERT ®

Loratadine Orally Disintegrating Tablet USP, 10 mg

Antihistamine

Indoor/Outdoor

ALLERGIES

24 Hour Relief of

Sneezing, Runny Nose

Itchy/Watery Eyes

Itchy Throat or Nose

Melts In Your Mouth

CITRUS BURST Flavor

*When taken as directed. See Drug Facts Panel.

VALUE SIZE 60 Orally Disintegrating Tablets


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)