Short Ragweed Pollen Allergen Extract Tablets

Name: Short Ragweed Pollen Allergen Extract Tablets

Indications

RAGWITEK™ is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. RAGWITEK is approved for use in adults 18 through 65 years of age.

RAGWITEK is not indicated for the immediate relief of allergic symptoms.

How supplied

Dosage Forms And Strengths

RAGWITEK is available as 12 Amb a 1-Unit (Amb a 1-U) tablets that are white to off-white, circular with a debossed double hexagon on one side.

Storage And Handling

RAGWITEK 12 Amb a 1-U tablets are white to off-white, circular sublingual tablets with a debossed double hexagon on one side.

RAGWITEK is supplied as follows:

3 blister packages of 10 tablets (30 tablets total). NDC 0006-5420-30
9 blister packages of 10 tablets (90 tablets total). NDC 0006-5420-54

Store at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted between 15°C- 30°C (59°F-86°F). Store in the original package until use to protect from moisture.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co Inc., Whitehouse Station, NJ 08889, USA. Manufactured by: Catalent Pharma Solutions Limited, Blagrove, Swindon, Wiltshire, SN5 8RU UK. Revised: April 2014

(web3)