Drospirenone And Ethinyl Estradiol
Product Images NDC 75834-115

10 FDA label images from Nivagen Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Drospirenone And Ethinyl Estradiol (NDC 75834-115). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nivagen Pharmaceuticals, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Image-01 (Image 01)

Image-01 (Image 01)
A forest plot displaying hazard ratios, rate ratios, and odds ratios from multiple studies including Ingenix, EURAS, LASS, FDA-funded, Danish, MEGA, German case-control, PharMetrics, and GPRD. The studies are categorized into prospective cohort, retrospective cohort, case-control, and non-fatal idiopathic cases only groups, with a horizontal axis logarithmically scaled from 0.1 to 10.*
FDA Label Image

Image-02 (Image 02)

Image-02 (Image 02)
A horizontal bar chart titled 'Likelihood of Developing a VTE' showing the estimated number of women developing blood clots per 10,000 women years. Categories include Non-Pregnant Non-COC users (range 1 to 5), COC-Users (range 3 to 9), Pregnancy (range 5 to 20), and Postpartum (12 weeks only) with the highest range of 40 to 65. Footnotes explain pregnancy data assumptions based on pregnancy duration.*
FDA Label Image

Image-03 (Image 03)

Image-03 (Image 03)
Chemical structure diagrams of Drospirenone and Ethinyl estradiol, the active ingredients in the product Drospirenone and Ethinyl Estradiol by Nivagen Pharmaceuticals, Inc.*
FDA Label Image

Image-04 (Image 04)

Image-04 (Image 04)
Pharmacokinetic data table for Drospirenone (DRSP) and Ethinyl Estradiol (EE) showing mean concentration (Cmax), time to maximum concentration (Tmax), area under the curve over 24 hours (AUC), and half-life (t1/2) values across multiple dosing cycles. Data include number of subjects, mean values with percentage coefficient of variation (%CV), and some half-life values marked as not available (NA).*
FDA Label Image

Image-05 (Image 05)

Image-05 (Image 05)
A warning panel directed to women who smoke, cautioning against the use of Yasmin if they are over 35 years old due to increased risk of serious cardiovascular side effects, including death from heart attack, blood clots, or stroke. The warning connects risk increase to age and number of cigarettes smoked.*
FDA Label Image

Image-06 (Image 06)

Image-06 (Image 06)
An illustration comparing pregnancy rates per 100 women in one year across various birth control methods. It ranks methods from fewer pregnancies, including implants, injections, intrauterine devices, sterilization, birth control pills, skin patch, and vaginal ring with hormones, to more pregnancies with condoms, diaphragm, no sex during fertile days, spermicide, withdrawal, and no birth control.*
FDA Label Image

Image-07 (Image 07)

Image-07 (Image 07)
An illustrated dosing and intake schedule for Drospirenone and Ethinyl Estradiol 3mg/0.03mg oral contraceptive tablets. The diagram shows a weekly layout from Sunday to Saturday with colored circles indicating yellow active tablets for the first 21 days and white inactive tablets for the last 7 days, guiding daily pill consumption.*
FDA Label Image

Image-08 (Image 08)

Image-08 (Image 08)
A bar chart showing the number of women with a blood clot per 10,000 women years among four groups: Non-Pregnant Non-COC users (range 1 to 5), COC users (range 3 to 9), Pregnant women (range 5 to 20), and Postpartum women within 12 weeks (range 40 to 65). The x-axis represents the number of women, and the y-axis lists the groups compared.*
FDA Label Image

Image-09 (Image 09)

FDA Label Image

Image-10 (Image 10)

Image-10 (Image 10)
Carton packaging for Drospirenone and Ethinyl Estradiol Tablets 3 mg / 0.03 mg by Nivagen Pharmaceuticals, Inc. The label indicates 3 blister cards of 28 tablets each. It includes usage instructions, manufacturer details, storage information, and warning that the product is a contraceptive intended to prevent pregnancy but does not protect against HIV or other sexually transmitted diseases. The packaging features the Nivagen logo and a barcode.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.