Short answer: The Osphena label dose is one 60 mg tablet taken by mouth once daily with food, for both painful sex and vaginal dryness from menopause. There is a single strength and no step-up. It is used for the shortest duration consistent with treatment goals and risks, with periodic checks on whether it is still needed. The label gives no missed-dose instruction.
This is what the FDA label says. Follow your prescriber. Your prescriber may use a different dose or pace than the label's standard schedule.
What Osphena is approved for: Osphena is an estrogen agonist/antagonist approved to treat moderate to severe dyspareunia (pain during sex) and moderate to severe vaginal dryness, both symptoms of vulvar and vaginal atrophy due to menopause (sections 1.1, 1.2). It acts like estrogen in the lining of the uterus but can act differently in other tissues (section 5.2).
Source
OSPHENA (ospemifene) tablets, for oral use, prescribing information and Patient Information. Duchesnay USA. DailyMed, version published February 17, 2025. DailyMed setid 9accbcc9-78ee-4f84-9b7e-704f2ab1c413
One 60 mg tablet is taken by mouth once daily with food (sections 2.1, 2.2). The tablet is white to off-white, oval and engraved with "60" (section 3).
Osphena is used for the shortest duration consistent with treatment goals and risks, and postmenopausal women are re-evaluated periodically to see whether treatment is still necessary (section 2).
The table below is the label's schedule, from the Dosage and Administration section. Numbers are copied exactly; the section is in brackets.
| Item | What the label says |
|---|---|
| Dyspareunia due to menopause | One 60 mg tablet taken orally with food once daily |
| Vaginal dryness due to menopause | One 60 mg tablet taken orally with food once daily |
| Strength | 60 mg tablet |
| Kidney impairment | No dose adjustment required |
| Mild or moderate liver impairment | No dose adjustment required |
| Severe liver impairment | Do not use |
If feasible, Osphena is stopped at least 4 to 6 weeks before surgery linked to a higher risk of blood clots, or during long immobilization.
Osphena is not used together with estrogens or estrogen agonist/antagonists, fluconazole or rifampin (sections 7.1 to 7.3).
Use of a progestin with Osphena was not evaluated in the clinical trials.
Osphena is contraindicated in women who are or may become pregnant.
The Osphena label gives no missed-dose instruction in the prescribing information or Patient Information. It says to take Osphena exactly as the healthcare provider says. Ask your prescriber or pharmacist what to do if a dose is missed.
In Dose Track you set up Osphena as a protocol with the dose and schedule your prescriber gave you. A protocol can hold dose steps, each with its own dose and length in days or weeks, so a step-up plan like the one on the label can be entered once and the app moves to the next step on its own. Reminders follow the schedule, and every dose is logged with the date and time, so you can see which step you are on and when your last dose was. The app follows what you enter; it does not choose or change a dose.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.