Isotretinoin Capsule, Liquid Filled
Product Images NDC 69238-1017
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Product Visual Gallery
This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Isotretinoin (NDC 69238-1017). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Amneal Pharmaceuticals Ny 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.
Product Images & Figures Index
40 Blister (Isotretinoin Capsules Usp 10)
This is a warning against the use of Isotretinoin Capsules, USP by pregnant women as it can cause serious birth defects. Even small amounts of the drug taken during pregnancy can lead to severe internal and external defects. The warning also advises female patients to take two separate and effective forms of birth control for at least one month before, during, and for one month after taking the medication. Monthly treatment cannot be received without proof of negative lab pregnancy test results. The drug should be stopped immediately and a doctor should be consulted if a patient becomes pregnant or misses a period while on the medication. The medication should be stored in a temperature-controlled environment, away from light.*
40 mg Carton (Isotretinoin Capsules Usp 11)
This is a warning and instruction label on a prescription medicine called Isotretinoin Capsules, USP, containing 40mg isotretinoin. The medicine is sold in Prescription Blister Packs, each of which contains 10 capsules, and is used to treat skin problems. The medicine should be dispensed only for registered patients after obtaining authorization from the iPLEDGE program by calling 1-866-495-0654 or visiting www.ipledgeprogram.com. The box is NOT to be kept in light and is contraindicated in pregnancy as it causes birth defects. There are also reminders and instructions for pharmacists for dispensing the medicine.*
Chem Structure (Isotretinoin Capsules Usp 2)
10 mg Blister (Isotretinoin Capsules Usp 3)
This text is a warning message regarding the use of Isotretinoin Capsules, which can cause severe birth defects in pregnant women. The message highlights that women should not take the medication if they are pregnant or planning to get pregnant, and must use two effective forms of birth control while taking the drug and for one month after discontinuing it. The patient must have negative pregnancy tests before starting the treatment and get a new one every month during treatment to continue receiving the medication. The text also describes possible birth defects that may occur and urges patients to contact their doctor immediately if they miss a period, suspect pregnancy, or have sex without birth control. Finally, the manufacturer is identified, and storage instructions are provided.*
10 Blister Part 2 (Isotretinoin Capsules Usp 4)
This is a warning label for Isotretinoin Capsules, USP - a drug used to treat severe acne. The label warns about the serious birth defects caused by isotretinoin and advises to not take the drug while pregnant. It also lists possible side effects such as nausea, headache, changes in vision and mental problems such as depression and suicidal thoughts. Patients are advised to read all the information provided with the prescription, including the Medication Guide, and sign a Patient Information/Informed Consent form before taking the drug. It is also emphasized that isotretinoin should not be shared with anyone else. Without more context, it is unclear what the random letters and symbols at the end of the text are supposed to represent.*
10 mg Carton (Isotretinoin Capsules Usp 5)
This is a warning and prescription label for a medication named "Isotretinoin Capsules, USP". The drug is known to cause birth defects and therefore, strict precautions must be taken by female patients to avoid pregnancy. The capsules come in the 10mg strength and a pack of 30 capsules. The medication must be protected from light and must be dispensed only by pharmacists authorized by the iPLEDGE program. The medication guide and important prescribing information is included in each prescription pack. Stores must maintain the temperature between 20 to 25°C (68 to 77°F) for storage.*
20 Blister (Isotretinoin Capsules Usp 6)
This text contains a warning message to female patients who are prescribed Isotretinoin Capsules, USP. The warning states that the medication can cause serious birth defects, and pregnant women or those planning to conceive within a month should not take it. Female patients must have negative pregnancy tests and interact with the iPledge system before receiving the medicine. They must also use two separate and effective forms of birth control during treatment, and monthly negative pregnancy tests are required to refill the prescription. The text also describes the severe internal and external defects caused by the medication. The capsules must be stored at room temperature and protected from light.*
20 mg Carton (Isotretinoin Capsules Usp 7)
The text contains information about isotretinoin capsules, a prescription medication used for treating severe acne. The text includes the medication's name, dosage, description, instructions for use, and warnings of possible birth defects when used by pregnant women. The control of treatment is carried out by the iPLEDGE program, and the medication should be dispensed only by registered pharmacists. The text also provides instructions for dispensing only a 30-day supply, storing the medication correctly, and handling prescription packs with care.*
30 Blister (Isotretinoin Capsules Usp 8)
This text contains important information warning female patients about the potential severe birth defects that can occur due to taking Isotretinoin Capsules, USP. The text outlines the warning signs and requirements for pregnancy tests and forms of birth control prior to treatment. It also includes definitions of the types of severe birth defects that have occurred as a result of taking Isotretinoin capsules. Overall, the text is an important warning and information for female patients to consider before taking this medication.*
30 mg Carton (Isotretinoin Capsules Usp 9)
Isotretinoin Capsules, USP are a prescription medication that must be exclusively dispensed to registered patients. It contains 30 mg isotretinoin USP and is supplied in three prescription blister packets of 10 capsules each, which should be dispensed intact. Dispensation of more than a 30-day supply is prohibited, and no refills are allowed. The blister packs comply with child-resistant packaging requirements. Pharmacists are advised to call the iPLEDGE program at 1-866-495-0654 or visit www.ipledgeprogram.com to obtain authorization before dispensing the medication. The package includes warnings about the dangers it poses to unborn children and prohibits its use in pregnant women. A medication guide is included in each prescription blister pack.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.