Safyral Kit
Product Images NDC 50419-403

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Safyral (NDC 50419-403). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bayer Healthcare 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

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Safyral oral tablet in a kit dosage form by Bayer HealthCare Pharmaceuticals Inc. The round, brown tablet features an imprint of a hexagon with a "Y+" inside on one side and is plain on the other. The image includes a millimeter scale for size reference.*

FDA Label Image

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Safyral round beige tablet imprinted with a hexagon enclosing 'M+' on one side, and a plain surface on the other. This oral dosage form is part of a kit containing drospirenone, ethinyl estradiol, levomefolate calcium, manufactured by Bayer HealthCare Pharmaceuticals Inc.*

FDA Label Image

Structural Formula (81e02158 706e 4e03 88c7 1990a0d6cd9d 03)

Chemical structure diagrams of the active ingredients in Safyral: Drospirenone, Ethinyl estradiol, and Levomefolate Calcium, showing their molecular arrangements and bonds.*

FDA Label Image

Figure 3 (81e02158 706e 4e03 88c7 1990a0d6cd9d 04)

A graph showing plasma folate levels (nmol/L) over 24 weeks comparing two treatment groups: YAZ with levomefolate calcium and YAZ alone. The x-axis represents time in weeks, and the y-axis represents plasma folate concentration. Data points with error bars illustrate mean levels and variability for each group across the study period.*

FDA Label Image

Figure 4 (81e02158 706e 4e03 88c7 1990a0d6cd9d 05)

A line graph comparing two groups over 24 weeks: one treated with YAZ plus levomefolate calcium (N=122) and the other with YAZ alone (N=44). The vertical axis represents a numeric measure with values ranging from 0 to 2000, and the horizontal axis denotes time in weeks from pre-treatment to 24 weeks. Data points show mean values with error bars.*

FDA Label Image

Figure 5 (81e02158 706e 4e03 88c7 1990a0d6cd9d 06)

A line chart depicting changes in a measured variable over time (weeks) for Yasmin combined with levomefolate calcium in a sample size of 75. The timeline on the x-axis spans from pre-treatment through treatment and elimination phases, with the y-axis showing the variable's values and associated error bars. Baseline values are indicated for comparison.*

FDA Label Image

Figure 6 (81e02158 706e 4e03 88c7 1990a0d6cd9d 07)

A line graph showing changes in RBC folates (nmol/L) over time (weeks) for a group taking Yasmin plus levomefolate calcium (N=75). The x-axis represents weeks from pre-treatment to 44 weeks, divided into treatment and elimination phases. The y-axis shows RBC folate levels with error bars indicating variability. A baseline is marked at week 24, highlighting folate level trends during and after treatment.*

FDA Label Image

Pregnancy Chart (81e02158 706e 4e03 88c7 1990a0d6cd9d 08)

A vertical efficacy chart illustrating pregnancy rates per 100 women in one year associated with different birth control methods. The chart orders methods from fewer pregnancies at the top (implants, injections, intrauterine devices, sterilization) to more pregnancies at the bottom (no birth control). Intermediate methods include birth control pills, skin patches, vaginal rings with hormones, condoms, diaphragms, abstinence during fertile days, spermicides, and withdrawal.*

FDA Label Image

Blister Image (81e02158 706e 4e03 88c7 1990a0d6cd9d 09)

Safyral kit blister pack showing circular tablet compartments arranged in four rows. The pack is labeled with the proprietary name Safyral and active ingredients drospirenone, ethinyl estradiol, and levomefolate calcium. It includes directions to place day labels and arrows indicating the tablet-taking sequence.*

FDA Label Image

Likelihood Of Developing A Serious Blood Clot (81e02158 706e 4e03 88c7 1990a0d6cd9d 10)

A horizontal bar chart illustrating the number of women with a blood clot per 10,000 women years across 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 at 12 weeks (range 40 to 65). The chart includes a note that pregnancy data is based on actual pregnancy duration with a model assumption of nine months duration.*

FDA Label Image

Trade Carton.jpg (81e02158 706e 4e03 88c7 1990a0d6cd9d 11)

Safyral 3 mg/0.03 mg/0.451 mg kit carton for oral tablets, containing drospirenone, ethinyl estradiol, and levomefolate calcium. This prescription drug packaging is labeled with Bayer HealthCare Pharmaceuticals Inc. and indicates a 3-unit package with 3 x 28 tablets per unit.*

FDA Label Image

Image 01

A forest plot chart depicting various cohort and case-control studies with hazard ratios, rate ratios, and odds ratios. The horizontal axis is logarithmic, ranging from 0.1 to 10, representing relative risk measures. Studies are grouped by prospective cohort studies, retrospective cohort studies, case-control studies, and non-fatal idiopathic cases only. Data points show effect sizes with confidence intervals for each study.*

FDA Label Image

Image 02

A horizontal bar chart showing the number of women with a blood clot out of 10,000 women years for four groups: 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 from 40 to 65. The chart includes a note that pregnancy data is based on the actual duration in reference studies, with a modeled pregnancy duration of nine months.*

FDA Label Image

Image 03

A forest plot chart titled 'Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives.' The chart compares risk estimates of breast cancer between ever users versus never users and current users versus never users of combined oral contraceptives. It includes study names, years, effect estimates, and confidence intervals plotted along a horizontal axis labeled 'Effect Estimate,' ranging from -1.5 to 2.0.*

* 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.