Mono-linyah Kit
Product Images NDC 67296-2329

11 FDA label images from Redpharm Drug · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Mono-linyah (NDC 67296-2329). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Redpharm Drug, 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

Figure1 (Figure1)

Figure1 (Figure1)
A forest plot chart comparing effect estimates (Odds Ratio, Relative Risk, Hazard Ratio) from multiple studies on contraceptive use. It includes data from NICHD Women’s Care Study, French E3N cohort, Shanghai Women’s Health Study, Nurses’ Health Study II, Oxford Family Planning Study, and Danish Sex Hormone Register Study. The plot displays effect estimates with 95% confidence intervals for 'Ever COC use vs. Never COC Use' and 'Current COC use vs. Never-Use.' The x-axis represents effect estimates ranging from -1.5 to 2.0.*
FDA Label Image

3 (Image 03)

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

5 (Image 05)

5 (Image 05)
A label showing manufacturing information for Mono-Linyah, a kit containing norgestimate and ethinyl estradiol. The label states the product is manufactured for Northstar Rx LLC in Memphis, Tennessee, and by Novast Laboratories Ltd. in Nantong, China.*
FDA Label Image

6 (Image 06)

6 (Image 06)
An illustration showing comparative pregnancy rates per 100 women per year associated with different birth control methods. The chart ranges from fewer pregnancies (1 pregnancy) to more pregnancies (85 or more), listing methods such as implants, injections, intrauterine devices, sterilization, birth control pills, skin patches, vaginal rings with hormones, condoms, diaphragm, no sex during fertile days, spermicide, withdrawal, and no birth control.*
FDA Label Image

7 (Image 07)

7 (Image 07)
An illustration of a Mono-Linyah oral contraceptive pill kit schedule showing pill-taking directions from left to right for each week. It differentiates week 1 with blue pills and week 4 with white pills, and includes reminders for taking the pill, such as after missed pills instructions and monthly self-breast exams.*
FDA Label Image

8 (Image 08)

8 (Image 08)
An instructional diagram showing a hand peeling off a day label (MON, TUE, WED, THU, FRI, SAT, SUN) to place it on a Mono-Linyah birth control pill kit. The kit displays rows of pills labeled by weeks with instructions to pick and stick the correct day label on the kit.*
FDA Label Image

9 (Image 09)

FDA Label Image

10 (Image 10)

10 (Image 10)
Mono-Linyah (norgestimate and ethinyl estradiol) tablets, USP 0.25 mg / 0.035 mg kit carton. The packaging indicates 6 blister packs with 28 tablets each intended for a 28-day regimen. The label shows the product name, active ingredients, strength, and includes storage instructions, lot, expiration, and barcode details. The labeler is Northstar Healthcare Holdings Ltd.*
FDA Label Image

Table1 (Table1)

Table1 (Table1)
A text panel titled 'Instructions for Administration of Mono-Linyah' detailing how to start and switch to Mono-Linyah oral contraceptive tablets. It includes guidance for beginning on Day 1 or Sunday, tablet color coding for active and inactive pills, and instructions for switching from various contraceptive methods such as transdermal patch, vaginal ring, injection, IUD, and implant. Advises on non-hormonal contraceptive use in specific cases.*
FDA Label Image

Table2 (Table2)

Table2 (Table2)
Table titled 'Instructions for Missed Mono-Linyah' listing specific guidance on actions to take when one or two active tablets are missed during various weeks of the dosing schedule. Instructions include timing for taking missed tablets and recommendations for additional non-hormonal contraception as back-up within 7 days after missing tablets.*
FDA Label Image

Table3 (Table3)

Table3 (Table3)
A data table titled 'Summary of NGMN, NG and EE pharmacokinetic parameters' showing mean and standard deviation values for peak serum concentration (Cmax), time to peak concentration (tmax), area under serum concentration curve (AUC0-24h), and elimination half-life (t1/2) for Norgestimate (NGMN and NG) and Ethinyl Estradiol (EE) at different cycles and days during a three-cycle study of 0.25mg/0.035mg tablets.*

* 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.