Alavert ®

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Anhydrous Citric Acid Polysorbate 80 Mannitol Pullulan

Identifiers & Packaging

Pill Appearance

Imprint: M24 Shape: round Color: white Size: 12 mm Score: 1

Marketing Status

ANDA Active Since 2024-05-01

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 disentigrates with or without water.


adults and children 6 years and over	1 tablet daily; do not use more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers who have liver or kidney disease	ask a doctor

Other Information

safety sealed: do not use if the individual blister unit printed with Alavert® Mint 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, mannitol, peppermint flavor, 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 10 Mg 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

FRESH MINT Flavor

*When taken as directed. See Drug Facts Panel.

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 disentigrates with or without water.


adults and children 6 years and over	1 tablet daily; do not use more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers who have liver or kidney disease	ask a doctor

Other Information (Other information)

safety sealed: do not use if the individual blister unit printed with Alavert® Mint 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, mannitol, peppermint flavor, 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 10 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 mg 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

FRESH MINT Flavor

*When taken as directed. See Drug Facts Panel.

60 Orally Disintegrating Tablets

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PULLULAN", "unii": "8ZQ0AYU1TT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "When using this product do not use more than directed. Taking more than recommended may cause drowsiness.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "Directions": "Place 1 tablet on tongue; tablet disentigrates with or without water. adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers who have liver or kidney disease ask a doctor", "Other information": "safety sealed: do not use if the individual blister unit printed with Alavert® Mint 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, mannitol, peppermint flavor, 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 - 10 mg 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 FRESH MINT Flavor *When taken as directed. See Drug Facts Panel. 60 Orally Disintegrating Tablets"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information