Philith Kit
Product Images NDC 16714-347

10 FDA label images from Northstar Rx Llc · 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 Philith (NDC 16714-347). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northstar Rx Llc, 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)
Chemical structures of the active ingredients norethindrone and ethinyl estradiol. The image shows the molecular formulas and weights for norethindrone (C20H26O2, molecular weight 298.42) and ethinyl estradiol (C20H24O2, molecular weight 296.40).*
FDA Label Image

Image-02 (Image 02)

Image-02 (Image 02)
A boxed warning text panel describing the increased risk of serious cardiovascular side effects from oral contraceptive use in women who smoke, especially those over 35 years old and heavy smokers (15 or more cigarettes per day). It advises women using oral contraceptives to strongly avoid smoking.*
FDA Label Image

Image-03 (Image 03)

Image-03 (Image 03)
A bar graph titled 'Circulatory Disease Mortality Rates Per 100,000 Women-Years by Age, Smoking Status and Oral Contraceptive Use.' It compares mortality rates among four groups (ever-users nonsmokers, controls nonsmokers, ever-users smokers, controls smokers) across four age ranges (15-24, 25-34, 35-44, 45+). The vertical axis represents mortality rate, number of deaths per 100,000 woman years. The highest mortality rate appears in ever-user smokers aged 45 and over.*
FDA Label Image

Image Description (Image 10)

Image Description (Image 10)
A forest plot chart displaying effect estimates (odds ratios or relative risks) with confidence intervals for various cohort studies on contraceptive use, including NICHD Women's Contraceptive Study, French E3N cohort, Shanghai Women's Health Study, Nurses' Health Study II, Oxford Family Planning Association Study, and Danish Sex Hormone Register Study. The horizontal axis represents effect estimates from approximately -1.5 to 2.0, with most estimates clustered around 1.0.*
FDA Label Image

Image-04 (Image 04)

Image-04 (Image 04)
A boxed warning text panel stating that cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use, with higher risk for women over 35 years old and heavy smokers (15 or more cigarettes per day). It strongly advises women who use oral contraceptives not to smoke.*
FDA Label Image

Image (Image 05)

Image (Image 05)
A boxed warning text panel highlighting the increased risk of serious cardiovascular side effects from oral contraceptive use associated with cigarette smoking, especially in women over 35 years of age or those who smoke 15 or more cigarettes per day, advising women using oral contraceptives not to smoke.*
FDA Label Image

Image-05 (Image 06)

Image-05 (Image 06)
Philith Kit of Norethindrone and Ethinyl Estradiol Tablets, oral contraceptive kit with 28 tablets arranged in a blister card. The 4-week supply includes 21 tan active tablets and 7 white inactive tablets, organized by days of the week. Label indicates storage and handling instructions and the labeler Northstar Rx LLC.*
FDA Label Image

Image-06 (Image 07)

Image-06 (Image 07)
An instructional illustration showing a hand peeling off a day label strip to place on the Philith oral contraceptive tablet kit. The day labels range from Monday to Sunday, and the diagram includes an example placement on the tablet kit to assist users in tracking daily tablet intake.*
FDA Label Image

Image-07 (Image 08)

FDA Label Image

Image-08 (Image 09)

Image-08 (Image 09)
Packaging label for Philith Kit containing Norethindrone and Ethinyl Estradiol Tablets, USP, 0.4 mg/0.035 mg, oral dosage form. The label shows a 28-day regimen with 6 blister packs of 28 tablets each. Labeler is Northstar Rx LLC, NDC 16714-347-04. The design includes text warnings, directions, and a floral graphic.*

* 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.