Mono-linyah Kit
Product Images NDC 16714-360

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 Mono-linyah (NDC 16714-360). 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

1 (Image 01)

1 (Image 01)
Text table titled 'Instructions for Administration of Mono-Linyah' outlining guidance on when to start taking Mono-Linyah kits based on current contraceptive use. Includes instructions for Day 1 Start, Sunday Start, and switching from other contraceptive methods such as transdermal patch, vaginal ring, injection, intrauterine contraceptive, and implant. Notes emphasize using additional non-hormonal contraception to reduce pregnancy risk and refer to FDA-Approved Patient Labeling for complete instructions.*
FDA Label Image

2 (Image 02)

2 (Image 02)
Table titled 'Instructions for Missed Mono-Linyah Tablets' outlining guidance for missed tablets during different weeks. It advises when to take missed tablets, whether to continue the pack or start a new one, and emphasizes use of additional non-hormonal contraception if sex occurs within 7 days after missing tablets. The table is structured with conditions on the left and instructions on the right.*
FDA Label Image

3 (Image 03)

3 (Image 03)
Chemical structure diagram showing the molecular formulas of norgestimate and ethinyl estradiol, the active ingredients in the prescription drug Mono-Linyah.*
FDA Label Image

4 (Image 04)

4 (Image 04)
A data table titled 'Summary of norelgestromin, norgestrel and ethinyl estradiol pharmacokinetic parameters,' presenting mean and standard deviation values for pharmacokinetic parameters of norgestimate and ethinyl estradiol 0.25mg/0.035mg tablets during a three-cycle study. Parameters include Cmax, tmax, AUC0-24h, and t½ for analytes NGMN, NG, and EE across different cycles and days, with explanatory notes defining the abbreviations and units used in the table.*
FDA Label Image

5 (Image 05)

5 (Image 05)
Label showing manufacturing information for Mono-Linyah, a human prescription drug kit containing norgestimate and ethinyl estradiol. Manufactured for Northstar Rx LLC, Memphis, TN, and by Novast Laboratories Ltd., Nantong, China. Includes a toll-free contact number.*
FDA Label Image

6 (Image 06)

6 (Image 06)
An illustration depicting the relative effectiveness of various birth control methods on pregnancy rates per 100 women in one year. It categorizes methods from 'Fewer pregnancies' at the top, including implants, injections, intrauterine devices, and sterilization, to methods with higher pregnancy rates such as birth control pills, skin patches, vaginal rings with hormones, condoms, diaphragm, spermicides, withdrawal, and no birth control at the bottom with the highest pregnancy rate.*
FDA Label Image

7 (Image 07)

7 (Image 07)
Mono-Linyah kit contains norgestimate and ethinyl estradiol tablets arranged in a weekly dosing schedule. The label shows a 28-tablet blister pack with blue and white tablets organized from Sunday to Saturday across four weeks. Instructions are provided to take the pills from left to right each week. The product is labeled by Northstar Rx LLC.*
FDA Label Image

8 (Image 08)

8 (Image 08)
An instructional illustration showing how to pick and place a correct day label on a Mono-Linyah kit blister pack for norgestimate and ethinyl estradiol. The diagram includes a hand peeling a day-label strip to align with the blister tablets marked by days of the week. Pills are color-coded as blue and white for weekly dosage.*
FDA Label Image

9 (Image 09)

FDA Label Image

10 (Image 10)

10 (Image 10)
Packaging label for Mono-Linyah, a prescription drug kit containing norgestimate and ethinyl estradiol tablets, USP, with a strength of 0.25 mg/0.035 mg. The label shows a 28-day regimen with 6 blister packs of 28 tablets each. The labeler is Northstar Rx LLC. The label includes dosage information, product name, active ingredients, barcodes, and regulatory statements.*

* 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.