bed for purposes other than those listed in a Medication Guide. Do not use duloxetine delayed-release capsules for a condition for which it was not prescribed. Do not give duloxetine delayed-release capsules to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about duloxetine delayed-release capsules. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about duloxetine delayed-release capsules that is written for healthcare professionals.
For more information about duloxetine delayed-release capsules call 1-269-544-2299.
What are the ingredients in duloxetine delayed-release capsules?
Active ingredient: duloxetine hydrochloride, USP
Inactive ingredients:
Gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate. Additionally, the 20 mg capsules contain FD&C Blue No. 2 and black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), the 30 mg capsules contain FD&C Blue No. 1, FD&C Red No. 40, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac) and white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide), and the 60 mg capsules contain FD&C Blue No. 2, iron oxide yellow and white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).
This Medication Guide has been approved by the U.S. Food and Drug Administration.
*The brands listed are trademarks of their respective owners.
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Manufactured by:
TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.
For:
TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920.
8063412 Revised February 2017
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Duloxetine Delayed-Release Capsules, USP 20mg
Label-20 mg
Duloxetine Delayed-Release Capsules, USP 30 mg
40 mg - label
Duloxetine Delayed-Release Capsules, USP 60 mg
60 mg - label
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INGREDIENTS AND APPEARANCE
DULOXETINE HYDROCHLORIDE
duloxetin hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-109
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U) DULOXETINE 20 mg
Inactive Ingredients
Ingredient Name
Strength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
GELATIN (UNII: 2G86QN3