DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Ethinyl Estradiol (0.03 mg) Levonorgestrel (0.15 mg)

Inactive Ingredients

Stearic Acid Starch, Corn Polyethylene Glycol 6000

Identifiers & Packaging

Pill Appearance

Shape: round Color: white Size: 5 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2018-11-21

Medication Information

Warnings and Precautions

Warnings/Precautions:

Smokers over 35yrs of age: not recommended. Uncontrolled hypertension. Hypertriglyceridemia. Discontinue if jaundice, visual disturbances, migraine or other severe headaches occur. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see literature). Nursing mothers: not recommended

Contraindications

Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X).

Interactions

Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's wort), possibly others. May affect measurement of sex hormone-binding globulin levels

Adverse Reactions:

Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, chloasma, mastodynia, headache, intolerance to contact lenses. Increased risk of gallbladder disease, thromboembolic disorders.

Indications and Usage

1 tab daily for 21 days; repeat.

Dosage and Administration

For oral use only

Description

Ethinyl Estradiol, Levonorgestrel

Section 50565-1

Keep out of reach of children

Section 51727-6

Stearic acid, corn starch, polyethylene glycol 6000

Section 51945-4

Section 55105-1

Oral contraception

Section 55106-9

Ethinyl Estradiol, Levonorgestrel

Structured Label Content

Indications and Usage (34067-9)

1 tab daily for 21 days; repeat.

Dosage and Administration (34068-7)

For oral use only

Warnings and Precautions (34071-1)

Warnings/Precautions:

Smokers over 35yrs of age: not recommended. Uncontrolled hypertension. Hypertriglyceridemia. Discontinue if jaundice, visual disturbances, migraine or other severe headaches occur. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see literature). Nursing mothers: not recommended

Contraindications

Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X).

Interactions

Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's wort), possibly others. May affect measurement of sex hormone-binding globulin levels

Adverse Reactions:

Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, chloasma, mastodynia, headache, intolerance to contact lenses. Increased risk of gallbladder disease, thromboembolic disorders.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Stearic acid, corn starch, polyethylene glycol 6000

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Oral contraception

Section 55106-9 (55106-9)

Ethinyl Estradiol, Levonorgestrel

Advanced Ingredient Data

[{"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 6000", "unii": "30IQX730WE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHINYL ESTRADIOL", "unii": "423D2T571U", "classCode": "ACTIB", "strengthNumerator": "0.03", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LEVONORGESTREL", "unii": "5W7SIA7YZW", "classCode": "ACTIB", "strengthNumerator": "0.15", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "1 tab daily for 21 days; repeat.", "34068-7": "For oral use only", "34071-1": "Warnings/Precautions: Smokers over 35yrs of age: not recommended. Uncontrolled hypertension. Hypertriglyceridemia. Discontinue if jaundice, visual disturbances, migraine or other severe headaches occur. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see literature). Nursing mothers: not recommended Contraindications Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X). Interactions Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's wort), possibly others. May affect measurement of sex hormone-binding globulin levels Adverse Reactions: Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, chloasma, mastodynia, headache, intolerance to contact lenses. Increased risk of gallbladder disease, thromboembolic disorders.", "50565-1": "Keep out of reach of children", "51727-6": "Stearic acid, corn starch, polyethylene glycol 6000", "55105-1": "Oral contraception", "55106-9": "Ethinyl Estradiol, Levonorgestrel"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information