Isotretinoin Capsule, Liquid Filled
Product Images NDC 68308-571

This is a medication for the treatment of acne called Isotretinoin. This medication comes in a capsule form and each capsule contains 10mg of Isotretinoin, USP. It is important to note that this medication can cause birth defects and individuals should not become pregnant while taking this medication. Pharmacists should dispense no more than a 30-day supply and must enroll in the IPLEDGE program. This text also contains information on product storage and reminders for pharmacists. The medication is manufactured in New Zealand and distributed by Mayne Pharma.*

This is a description of a medication called Isotretinoin. It comes in capsule form with 20 mg of Isotretinoin, USP. It is for prescription use only and is distributed by Mayne Pharma. It is contraindicated in pregnancy and should not be dispensed for more than a 30-day supply. The medication guide included in each prescription pack must be dispensed along with the medication. The pharmacy must call or visit the PLEDGE Program to obtain authorization to dispense this medication. The medication causes birth defects and should not be taken by pregnant women. It is important to protect the medication from light and store it at 20°C to 25°C. For additional dosage recommendations and important prescribing information, see the enclosed insert.*

This is a medication guide for Isotretinoin capsules, USP 30mg, to be dispensed by a pharmacist. The medication is known to cause birth defects, and pharmacists are reminded to only dispense for registered patients with authorization from the IPLEDGE Program. The recommended dose is a 30-day supply, and each Prescription Pack includes a Medication Guide. The product is distributed by Mayne Pharma and was manufactured in New Zealand. Stored between 20° to 25°C, it is contraindicated in pregnancy.*