Bath & Body Works, Inc.

Rub a dime sized drop into hands.

Spray hands thoroughly. Rub until dry.

Rub a dime sized drop into hands.

Wet hands, work into a rich lather Rinse well

Wet hands, work into a rich lather Rinse well

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: ask a doctor

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: ask a doctor

Spray liberally and spread evenly by hand 15 minutes before sun exposure.  Hold container 4 to 6 inches from skin to apply.  Do not spray directly into face.  Spray on hands then apply to face.  Do not apply in windy conditions.  Use in a well ventilated area. Reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: ask a doctor

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: ask a doctor

Wet hands, work into a rich lather. Rinse well.

2.1 Depressive Episodes Associated with Bipolar I Disorder

Adults — Administer SYMBYAX once daily in the evening, generally beginning with the 6 mg/25 mg (mg olanzapine/mg equivalent fluoxetine) capsule. While food has no appreciable effect on the absorption of olanzapine and fluoxetine given individually, the effect of food on the absorption of SYMBYAX has not been studied. Make dosage adjustments, if indicated, according to efficacy and tolerability. Antidepressant efficacy was demonstrated with SYMBYAX in a dose range of olanzapine 6 mg to 12 mg and fluoxetine 25 mg to 50 mg [see Clinical Studies (14.1)]. The safety of doses above 18 mg of olanzapine and 75 mg of fluoxetine has not been evaluated in adult clinical studies. Periodically reexamine the need for continued pharmacotherapy.

Children and Adolescents (10 to 17 years of age) — Administer SYMBYAX once daily in the evening, generally beginning with the 3 mg/25 mg capsule, without regard to meals, with a recommended target dose within the approved dosing range (6/25; 6/50; 12/25; 12/50 mg) [see Clinical Studies (14.1)]. The safety of doses above 12 mg of olanzapine and 50 mg of fluoxetine has not been evaluated in pediatric clinical studies. Periodically reexamine the need for continued pharmacotherapy.

2.2 Treatment Resistant Depression

Administer SYMBYAX once daily in the evening, generally beginning with the 6 mg/25 mg capsule. While food has no appreciable effect on the absorption of olanzapine and fluoxetine given individually, the effect of food on the absorption of SYMBYAX has not been studied. Adjust dosage, if indicated, according to efficacy and tolerability. Antidepressant efficacy was demonstrated with SYMBYAX in a dose range of olanzapine 6 mg to 18 mg and fluoxetine 25 mg to 50 mg [see Clinical Studies (14.2)]. The safety of doses above 18 mg/75 mg has not been evaluated in clinical studies. Periodically reexamine the need for continued pharmacotherapy.

2.3 Specific Populations

Start SYMBYAX at 3 mg/25 mg or 6 mg/25 mg in patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of SYMBYAX (female gender, geriatric age, nonsmoking status) or those patients who may be pharmacodynamically sensitive to olanzapine. Titrate slowly and adjust dosage as needed in patients who exhibit a combination of factors that may slow metabolism. SYMBYAX has not been systematically studied in patients >65 years of age or in patients <10 years of age [see Warnings and Precautions (5.19), Use in Specific Populations (8.5), and Clinical Pharmacology (12.3, 12.4)].

Treatment of Pregnant Women — When treating pregnant women with fluoxetine, a component of SYMBYAX, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalizations, respiratory support, and tube feeding. [see Use in Specific Populations (8.1)].

2.4 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with SYMBYAX. Conversely, at least 5 weeks should be allowed after stopping SYMBYAX before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].

2.5 Use of SYMBYAX with Other MAOIs such as Linezolid or Methylene Blue

Do not start SYMBYAX in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)].

In some cases, a patient already receiving SYMBYAX therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue are judged to outweigh the risks of serotonin syndrome in a particular patient, SYMBYAX should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with SYMBYAX may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.5)].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with SYMBYAX is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.5)].

2.6 Discontinuation of Treatment with SYMBYAX

Symptoms associated with discontinuation of fluoxetine, a component of SYMBYAX, SNRIs, and SSRIs, have been reported [see Warnings and Precautions (5.23)].

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.

Rub a dime sized drop into hands.