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Oral contraceptives package insert

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Generic Name: levonorgestrel and ethinyl estradiol Dosage Form: tablets. Medically reviewed by Drugs. Last updated on Aug 1, The inactive ingredients in the pink active tablets include anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose.
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U.S. Food and Drug Administration

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Portia - FDA prescribing information, side effects and uses

The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the benefits and the risks involved in their use. An oral contraceptive drug product that does not comply with the requirements of this section is misbranded under section of the Federal Food, Drug, and Cosmetic Act. Each dispenser of an oral contraceptive drug product shall provide a patient package insert to each patient or to an agent of the patient to whom the product is dispensed, except that the dispenser may provide the insert to the parent or legal guardian of a legally incompetent patient or to the agent of either. The patient package insert is required to be placed in or accompany each package dispensed to the patient. A patient package insert for an oral contraceptive drug product is required to contain the following:. The patient package insert may identify indications in addition to contraception that are identified in the professional labeling for the drug product.
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The patient's understanding of the oral contraceptive patient package insert.

The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the benefits and the risks involved in their use. An oral contraceptive drug product that does not comply with the requirements of this section is misbranded under section of the Federal Food, Drug, and Cosmetic Act. Each dispenser of an oral contraceptive drug product shall provide a patient package insert to each patient or to an agent of the patient to whom the product is dispensed, except that the dispenser may provide the insert to the parent or legal guardian of a legally incompetent patient or to the agent of either. The patient package insert is required to be placed in or accompany each package dispensed to the patient. A patient package insert for an oral contraceptive drug product is required to contain the following:.
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Medication should be discontinued immediately if migraine becomes focal, or if there is a loss of vision, or if there is an onset of unexplained chest pain. Relative contra-indications include a history of diabetes mellitus, epilepsy, asthma, hypertension, porphyria or states in which fluid retention occur. Combined oral contraceptives should be avoided in pregnancy and in patients who are breast feeding. Even though they rarely occur, you should be aware of them. Stop taking tablets and see your doctor immediately if you have persistent vaginal bleeding or discomfort, constant leg or chest pain, breathing difficulties, severe headache or vomiting, dizziness, difficulty seeing or talking, numb or weak feeling in an arm or leg, if you become very sad or irritable, if you cough up blood, or have other unusual symptoms.
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