Duloxetine 30 mg Delayed Release Capsules — Generic For Cymbalta — Ajanta

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SKU: 27241-0098-10-01
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Description

Duloxetine 30 mg Delayed Release Capsules is available by prescription only. Go ahead and place your purchase. After making payment, we will ensure that a valid prescription is received from your prescriber.

Drug Label Highlights

Source: This information is taken from the official DailyMed drug label page when available. It is provided for educational purposes and is not a substitute for pharmacist counseling, prescriber instructions, or the full official labeling.

These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES.

DULOXETINE delayed-release capsules, for oral use.

Initial U.S. Approval: 2004

Warning: Suicidal Thoughts And Behaviors

See full prescribing information for complete boxed warning.

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants (5.1)

Monitor for worsening and emergence of suicidal thoughts and behaviors (5.1)

Recent Major Changes

Warnings and Precautions (5.4, 5.5) 08/2023

Indications And Usage

Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions:

Major depressive disorder (MDD) in adults (1)

Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1)

Diabetic peripheral neuropathic pain (DPNP) in adults (1)

Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older (1)

Chronic musculoskeletal pain in adults (1)

Dosage And Administration

Take duloxetine delayed-release capsules once daily, with or without food. Swallow whole; do not crush, or chew, or open capsule (2.1)

Indication

Starting

Dose

Target Dose

Maximum

Dose

Mdd (2.2)

40 mg/day

to 60 mg/day

Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day

120 mg/day

Gad (2.3)

Adults

60 mg/day

60 mg/day (once daily)

120 mg/day

Geriatric

30 mg/day

60 mg/day (once daily)

120 mg/day

Pediatrics (7 years to 17 years of age)

30 mg/day

30 to 60 mg/day (once daily)

120 mg/day

Dpnp (2.4)

60 mg/day

60 mg/day (once daily)

60 mg/day

Fm (2.5)

Adults and Pediatrics (13 years to 17 years of age)

30 mg/day

60 mg/day (once daily)

60 mg/day

Chronic Musculoskeletal Pain (2.6)

30 mg/day

60 mg/day (once daily)

60 mg/day

Discontinuing duloxetine delayed-release capsules: Gradually reduce dosage to avoid discontinuation symptoms (2.8,5.7)

Dosage Forms And Strengths

Delayed-release capsules 20 mg, 30 mg, 40 mg and 60 mg (3)

Contraindications

Concomitant use of an MAOI antidepressant with duloxetine is contraindicated

Use of duloxetine within 14 days of stopping an MAOI antidepressant is contraindicated

In linezolid-or intravenous methylene blue-treated patients, initiation of duloxetine is contraindicated (4)

Warnings And Precautions

(5.4, 5.5) 08/2023 INDICATIONS AND USAGE Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions:
Major depressive disorder (MDD) in adults (1)
Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1)
Diabetic peripheral neuropathic pain (DPNP) in adults (1)
Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older (1)
Chronic musculoskeletal pain in adults (1) DOSAGE AND ADMINISTRATION
Take duloxetine delayed-release capsules once daily, with or without food. Swallow whole; do not crush, or chew, or open capsule (2.1) Indication Starting Dose Target Dose Maximum Dose MDD (2.2) 40 mg/day to 60 mg/day Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day 120 mg/day GAD (2.3) Adults 60 mg/day 60 mg/day (once daily) 120 mg/day Geriatric 30 mg/day 60 mg/day (once daily) 120 mg/day Pediatrics (7 years to 17 years of age) 30 mg/day 30 to 60 mg/day (once daily) 120 mg/day DPNP (2.4) 60 mg/day 60 mg/day (once daily) 60 mg/day FM (2.5) Adults and Pediatrics (13 years to 17 years of age) 30 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain (2.6) 30 mg/day 60 mg/day (once daily) 60 mg/day
Discontinuing duloxetine delayed-release capsules: Gradually reduce dosage to avoid discontinuation symptoms (2.8,5.7) DOSAGE FORMS AND STRENGTHS Delayed-release capsules 20 mg, 30 mg, 40 mg and 60 mg (3) CONTRAINDICATIONS

(5.4, 5.5) 08/2023 INDICATIONS AND USAGE Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions:
Major depressive disorder (MDD) in adults (1)
Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1)
Diabetic peripheral neuropathic pain (DPNP) in adults (1)
Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older (1)
Chronic musculoskeletal pain in adults (1) DOSAGE AND ADMINISTRATION
Take duloxetine delayed-release capsules once daily, with or without food. Swallow whole; do not crush, or chew, or open capsule (2.1) Indication Starting Dose Target Dose Maximum Dose MDD (2.2) 40 mg/day to 60 mg/day Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day 120 mg/day GAD (2.3) Adults 60 mg/day 60 mg/day (once daily) 120 mg/day Geriatric 30 mg/day 60 mg/day (once daily) 120 mg/day Pediatrics (7 years to 17 years of age) 30 mg/day 30 to 60 mg/day (once daily) 120 mg/day DPNP (2.4) 60 mg/day 60 mg/day (once daily) 60 mg/day FM (2.5) Adults and Pediatrics (13 years to 17 years of age) 30 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain (2.6) 30 mg/day 60 mg/day (once daily) 60 mg/day
Discontinuing duloxetine delayed-release capsules: Gradually reduce dosage to avoid discontinuation symptoms (2.8,5.7) DOSAGE FORMS AND STRENGTHS Delayed-release capsules 20 mg, 30 mg, 40 mg and 60 mg (3) CONTRAINDICATIONS

Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported. Discontinue duloxetine in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Avoid use in patients with substantial alcohol use or evidence of chronic liver disease (5.2)

Orthostatic Hypotension, Falls and Syncope: Consider dosage reduction or discontinuation if these events occur (5.3)

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents but also when taken alone. If it occurs, discontinue duloxetine and serotonergic agents (5.4)

Increased Risk of Bleeding: May increase the risk of bleeding events. Concomitant use of antiplatelet drugs and anticoagulants may increase this risk (5.5, 7.4,8.1)

Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur; Discontinue at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified. (5.6)

Activation of Mania or Hypomania: Prior to initiating, screen patients for personal or family history of bipolar disorder, mania, or hypomania (5.8)

Angle-Closure Glaucoma: Has occurred in patients with untreated anatomically narrow angles treated with antidepressants. (5.9)

Seizures: Prescribe with care in patients with a history of seizure disorder (5.10)

Blood Pressure Increases: Monitor blood pressure prior to initiating treatment and periodically throughout treatment (5.11)

Inhibitors of CYP1A2 or Thioridazine: Avoid co-administration with duloxetine (5.12)

Hyponatremia: Can occur in association with SIADH; consider discontinuation (5.13)

Glucose Control in Diabetes: In DPNP patients, increases in fasting blood glucose, and HbA1c have been observed (5.14)

Conditions that Slow Gastric Emptying: Use cautiously in these patients (5.14)

Sexual Dysfunction: Duloxetine may cause symptoms of sexual dysfunction (5.16)

Adverse Reactions

Most common adverse reactions (greater than or equal to 5% and at least twice the incidence of placebo-treated patients): (6.1).

Adults: nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis

Pediatric Patients: decreased weight, decreased appetite, nausea, vomiting, fatigue, and diarrhea

To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc. at 1-855-664-7744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Drug Interactions

Potent inhibitors of CYP1A2 should be avoided (7.1).

Potent inhibitors of CYP2D6 may increase duloxetine concentrations (7.2).

Duloxetine is a moderate inhibitor of CYP2D6 (7.9).

Use In Specific Populations

Pregnancy: Third trimester use may increase risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate (8.1)

Hepatic Impairment: Avoid use in patients with chronic liver disease or cirrhosis (5.14)

Renal Impairment: Avoid use in patients with severe renal impairment, GFR less than 30 mL/minute (5.14)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 8/2025

View Full DailyMed Label View DailyMed PDF

DailyMed highlights last updated: 2026-06-24 22:11:14

Additional information

Size/Count	1 Count
Dose/Strength	30 MG
Form	Capsule

Medication Guide

Official DailyMed Drug Label Information

This product has a DailyMed drug label PDF from the National Library of Medicine.

View / Download PDF View on DailyMed

Source: DailyMed, National Library of Medicine
DailyMed Label: DULOXETINE CAPSULE, DELAYED RELEASE [AJANTA PHARMA USA INC.]
Matched NDC: 27241-098-10
Published Date: Dec 08, 2025

Medication Summary

Medication Summary: This section summarizes DailyMed drug label information to make the label easier to understand. It is not a substitute for the official label, pharmacist counseling, prescriber instructions, or medical advice.

Overview

Duloxetine delayed-release capsules are a prescription medicine for oral use. It is a serotonin and norepinephrine reuptake inhibitor (SNRI) used for several conditions, including major depressive disorder in adults, generalized anxiety disorder in adults and pediatric patients 7 years and older, diabetic peripheral neuropathic pain in adults, fibromyalgia in adults and pediatric patients 13 years and older, and chronic musculoskeletal pain in adults.

The capsules are taken once daily, with or without food. They should be swallowed whole and not crushed, chewed, or opened, because that can affect the enteric coating.

The label includes a boxed warning about suicidal thoughts and behaviors, especially in children, adolescents, and young adults. The label also warns about serious risks such as serotonin syndrome, liver problems, bleeding, severe skin reactions, blood pressure increases, and other adverse effects.

If a dose is missed, the label says to take it when remembered unless it is almost time for the next dose; in that case, skip the missed dose and do not take two doses at the same time.

Storage Information

protected by the enteric coating, may undergo hydrolysis to form naphthol. protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. store duloxetine delayed-release capsules? Store duloxetine delayed-release capsules at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Key Counseling Points

Take the capsules once daily, with or without food, as directed on the prescription label.
Swallow the capsule whole; do not crush, chew, or open it.
If a dose is missed, take it when remembered unless it is almost time for the next dose.
Do not take two doses at the same time.
Tell a healthcare professional about all other medicines, especially MAOIs, linezolid, intravenous methylene blue, triptans, tramadol, lithium, and St. John's Wort.
Watch for symptoms of serotonin syndrome, such as agitation, hallucinations, fever, fast heartbeat, dizziness, sweating, tremor, stiffness, or diarrhea.
Report signs of liver problems, such as jaundice or other evidence of clinically significant liver dysfunction, right away.
Use caution about bleeding risk if taking aspirin, NSAIDs, warfarin, or other anticoagulants.
Seek urgent attention for severe skin reactions, including blistering, peeling rash, or mucosal erosions.
Do not stop the medicine suddenly unless instructed; the label says dosage should be reduced gradually when possible.

Helpful Patient Education

Duloxetine delayed-release capsules are an SNRI prescription medicine with several labeled uses, including major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain. The delayed-release capsule should be swallowed whole and not crushed, chewed, or opened so the enteric coating is preserved.

DailyMed labeling also highlights important safety information, including a boxed warning for suicidal thoughts and behaviors, plus risks such as serotonin syndrome, liver injury, bleeding, severe skin reactions, blood pressure increases, and withdrawal symptoms if stopped abruptly. This product information is intended to help patients understand the label-based uses, directions, and precautions for duloxetine delayed-release capsules.

Medication Summary last generated: 2026-07-05 12:29:43

Duloxetine 30 mg Delayed Release Capsules --- Generic For Cymbalta --- Ajanta may require patient-specific counseling based on your prescription, directions, allergies, medical history, and other medications.

This Medication Guide section is provided for general educational purposes only. It does not replace the official medication guide, patient information leaflet, counseling from your pharmacist, or medical advice from your prescriber.

Please read all information provided with your prescription. Contact Pill Pals Pharmacy or your prescriber with questions before using this medication.

Duloxetine 30 mg Delayed Release Capsules — Generic For Cymbalta — Ajanta

Description