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Cevimeline (Cevimeline) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.

DOSAGE AND ADMINISTRATION

The recommended dose of Cevimeline Hydrochloride is 30 mg taken three times a day. There is insufficient safety information to support doses greater than 30 mg tid. There is also insufficient evidence for additional efficacy of Cevimeline Hydrochloride at doses greater than 30 mg tid.

HOW SUPPLIED

Cevimeline Hydrochloride Capsules, 30 mg are available as white, hard gelatin capsules containing 30 mg of Cevimeline Hydrochloride. Cevimeline Hydrochloride Capsules are size 3 hard gelatin capsules with an opaque white cap and body. Cevimeline Hydrochloride capsules are imprinted with P 657 on both cap and body in black ink. Cevimeline Hydrochloride is supplied in child resistant bottles of:

100 capsules (NDC: 16571-657-10)

Store at 25°C (77°F) excursions permitted to 15°-30°C (59°-86°F)
[See USP Controlled Room Temperature].

Rx only

Distributed and Marketed by:
PACK Pharmaceuticals, LLC
Buffalo Grove, IL 60089

Manufactured by:
Mirror Pharmaceuticals LLC
Fairfield, NJ 07004

5516 Revised 3/14

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