cevimeline 30 MG Oral Capsule

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

Rising Pharmaceuticals, Inc.

FDA Reported Adverse Reactions
`[1] pain` `[2] drug ineffective` `[3] fatigue` `[4] nausea` `[5] drug hypersensitivity` `[6] headache` `[7] dyspnoea` `[8] vomiting` `[9] diarrhoea` `[10] arthralgia`

5 years ago

CAPSULE WHITE P 657

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 Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Rev. 07/24 551604 PIR65710-02

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cevimeline 30 MG Oral Capsule

FDA Reported Adverse Reactions [1] pain [2] drug ineffective [3] fatigue [4] nausea [5] drug hypersensitivity [6] headache [7] dyspnoea [8] vomiting [9] diarrhoea [10] arthralgia

CAPSULE WHITE P 657

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FDA Reported Adverse Reactions
`[1] pain` `[2] drug ineffective` `[3] fatigue` `[4] nausea` `[5] drug hypersensitivity` `[6] headache` `[7] dyspnoea` `[8] vomiting` `[9] diarrhoea` `[10] arthralgia`