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]

SPL UNCLASSIFIED SECTION

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 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

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

ALAVERT  ALLERGY
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69536-195
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)
ASPARTAME (UNII: Z0H242BBR1)
PULLULAN (UNII: 8ZQ0AYU1TT)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor	CITRUS	Imprint Code	C24
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69536-195-20	20 in 1 CARTON	10/31/2024
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 69536-195-60	60 in 1 CARTON	10/31/2024
2		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	10/31/2024

Labeler - Foundation Consumer Healthcare (079675882)