DOXEPIN HYDROCHLORIDE (Page 4 of 4)

HOW SUPPLIED

The 10 mg capsule is a hard-shell, gelatin capsule with a tan opaque cap and tan opaque body, axially printed with TARO over D10 in black ink on both the cap and the body. They are available as follows:

NDC: 70518-3020-00

PACKAGING: 30 in 1 BLISTER PACK

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Dispense with Medication Guide available at: https:// www.taro.com/usa-medication-guides

Medication Guide

Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with your or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.

Talk to your, or your family member’s, healthcare provider about:

• all risks and benefits of treatment with antidepressant medicines
• all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling very agitated or restless panic attacks trouble sleeping (insomnia)

What else do I need to know about antidepressant medicines? Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762 new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood Visual problems: eye pain, changes in vision, swelling or redness in or around the eye Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms. Visual problems: Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

DRUG: DOXEPIN HYDROCHLORIDE

GENERIC: DOXEPIN HYDROCHLORIDE

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-3020-0

COLOR: brown

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: TARO;D10

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• DOXEPIN HYDROCHLORIDE 10mg in 1

INACTIVE INGREDIENT(S):

• SILICON DIOXIDE
• GELATIN, UNSPECIFIED
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• STARCH, CORN
• SODIUM LAURYL SULFATE
• TITANIUM DIOXIDE
• FERRIC OXIDE RED
• FERRIC OXIDE YELLOW
• FERROSOFERRIC OXIDE
• POTASSIUM HYDROXIDE
• PROPYLENE GLYCOL
• SHELLAC

DOXEPIN HYDROCHLORIDE doxepin hydrochloride capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-3020(NDC:51672-4217) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN 10 mg

Inactive Ingredients Ingredient Name Strength GELATIN, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SODIUM LAURYL SULFATE TITANIUM DIOXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE

Product Characteristics Color brown (opaque) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code TARO;D10 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70518-3020-0 30 CAPSULE in 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213063 02/09/2021

Labeler — REMEDYREPACK INC. (829572556)

Revised: 09/2023 REMEDYREPACK INC.