Cenestin therapy is indicated for the:

1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.

0.45 mg Cenestin

0.625 mg Cenestin

0.9 mg Cenestin

1.25 mg Cenestin

2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

0.3 mg Cenestin

When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

1. For treatment of moderate to severe vasomotor symptoms associated with the menopause.

Cenestin 0.45 mg

Cenestin 0.625 mg

Cenestin 0.9 mg

Cenestin 1.25 mg

Patients should be started at Cenestin 0.45 mg daily. Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider. The lowest effective dose of Cenestin for the treatment of moderate to severe vasomotor symptoms has not been determined.

2. For treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

Cenestin 0.3 mg daily

Cenestin (synthetic conjugated estrogens, A) Tablets are available as:

0.3 mg: Round, green, film-coated, and are debossed with letters, dp, and number, 41. Available in bottles of:

30 NDC 51285-441-30

100 NDC 51285-441-02

1000 NDC 51285-441-05

0.45 mg: Round, orange, film-coated, and are debossed with letters, dp , and number, 46. Available in bottles of:

30 NDC 51285-446-30

100 NDC 51285-446-02

1000 NDC 51285-446-05

0.625 mg: Round, red, film-coated, and are debossed with letters, dp , and number, 42. AVAILABLE IN BOTTLES OF:

30 NDC 51285-442-30

100 NDC 51285-442-02

1000 NDC 51285-442-05

0.9 mg: Round, white, film-coated, and are debossed with letters, dp , and number, 43. Available in bottles of:

30 NDC 51285-443-30

100 NDC 51285-443-02

1000 NDC 51285-443-05

1.25 mg: Round, blue, film-coated, and are debossed with letters, dp , and number, 44. Available in bottles of:

30 NDC 51285-444-30

100 NDC 51285-444-02

1000 NDC 51285-444-05

Store at 20-25°C (68-77°F); excursions are permitted to15-30°C (59-86°F) [See USP Controlled Room Temperature].

Dispense in tight container.

Dispense in child-resistant packaging.

Pharmacist: Include one "Information for the patient" leaflet with each package dispensed.

Manufactured By: Duramed Pharmaceuticals, Inc., Subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970,

Revised SEPTEMBER 2004, BR - 41, 46, 42, 43, 44

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