ALAVERT ALLERGY- loratadine tablet, orally disintegrating

Alavert by

Drug Labeling and Warnings

Alavert by is a Otc medication manufactured, distributed, or labeled by Foundation Consumer Healthcare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

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

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 use more than directed. Taking more than recommended may cause drowsiness.

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

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

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

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

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Distributed by: Foundation Consumer Healthcare, LLC
Pittsburgh, PA 15212

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

INGREDIENTS AND APPEARANCE

ALAVERT  ALLERGY
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69536-190
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
MANNITOL (UNII: 3OWL53L36A)
PULLULAN (UNII: 8ZQ0AYU1TT)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor	MINT	Imprint Code	M24
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69536-190-60	60 in 1 CARTON	05/15/2024
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213294	05/01/2024

Labeler - Foundation Consumer Healthcare (079675882)