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And BOTOX(R) is approved for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.

BOTOX(R) Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18 - 65.

Important Safety Information

Who should not be treated with BOTOX(R) and BOTOX(R) Cosmetic

BOTOX(R) injections should not be given to people who have an infection where the physician proposes to inject. They should not be given to people who are known to be sensitive to any ingredient in the BOTOX(R) product.

Warnings

Serious heart problems and serious allergic reactions have been reported rarely. If you think you're having an allergic reaction or other reaction, such as difficulty swallowing, speaking, or breathing, call your doctor immediately.

Patients with certain neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects.

Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia (difficulty swallowing) and respiratory compromise from typical doses of BOTOX(R) and BOTOX(R) Cosmetic.

Dysphagia (difficulty swallowing) is a commonly reported adverse event following treatment of cervical dystonia patients with all botulinum toxins. In these patients, there are reports of rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube.

Precautions

Patients or caregivers should be advised to seek immediate medica
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