Isotretinoin Structure Formula (74c2a67e 7556 4f75 B9fe 5f6e1e4a14ba 02)
Amnesteem Capsule
Product Images NDC 0378-6614
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Product Visual Gallery
This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Amnesteem (NDC 0378-6614). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Mylan 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.
Product Images & Figures Index
Do Not Get Pregnant Causes Birth Defects (Image 01)
This is a warning label indicating that the substance can cause birth defects and advises not to get pregnant while in contact with it.*
Amnesteem Capsules, Usp 10 mg Carton Label (Image 02)
Amnesteem Capsules, Usp 20 mg Carton Label (Image 03)
Amnesteem is a medication that comes in capsules and is used to treat acne. It contains isotretinoin and must be taken with care to avoid pregnancy. Patients should not use it during pregnancy. The manufacturer, Mylan Pharmaceuticals, requires pharmacists to obtain authorization before dispensing this medication to registered patients by calling 1-866-495-0654 or visiting www.pledgeprogram.com. Each prescription pack has a patient medication guide included. The medication should be stored between 68-77°F and must be protected from light. Dosage recommendations and other important prescribing information are available in the accompanying insert.*
Amnesteem Capsules, Usp 40 mg Carton Label (Image 04)
Image 05
This is a medication guide for Amnesteem (Isotretinoin Capsules, USP). It includes important instructions for pharmacists, such as only dispensing to registered patients after obtaining authorization from the PLEDGE REMS program, and reminders for patients to avoid pregnancy while taking the medication. It is contraindicated in pregnancy. The usual dosage is not specified, so it is not available. However, it is stated that each capsule contains 20 mg isotretinoin. The medication guide also includes storage instructions and the manufacturer's trademark.*
Image 06
Image 07
Amnesteem’ is a medication that contains isotretinoin capsules used to treat severe nodular acne. The drug can cause severe birth defects if taken during pregnancy, and warnings exist for the patient to avoid getting pregnant. Pharmacists are only allowed to dispense the drug to registered patients who obtain authorization from the PLEDGE REMS program. The authorized dosage comes in a 30-day supply with a medication guide included in each prescription pack. The prescribed packs should remain intact until dispensed, and it must have a unique risk management authorization number on the prescription. The medication should be stored in a controlled room temperature of between 20° and 26°C, away from light.*
* 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.
