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Patient Information
Patients: If you have a medical emergency call 911

It is our policy to provide technical information on prescription products to Pharmacists and Physicians only. Patients/consumers should contact their HealthCare Provider with any questions regarding prescription products and their uses.

Patient Information

Patient Information Sheets encourage patients to talk with their healthcare providers for further information. Patient Information Sheets also provide telephone and e-mail contact information for FDA’s Drug Information line to address specific questions. FDA continues to collect input on the usefulness of these consumer communications through feedback mechanisms, such as focus groups, surveys, and public meetings, and anticipates that these consumer communications will continue to evolve.
Source:  Drug Safety Information- FDA’s Communication to the Public.

Medication Guides

21 CFR section 208.1(c) authorizes FDA to require a Medication Guide if FDA determines one or more of the following circumstances exist:

(1) The drug product is one for which patient labeling could help prevent serious adverse effects.

(2) The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risks could affect patients’ decision to use, or continue to use, the product.

(3) The drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.  
 

Product Search
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Product Name NDC/ID
Anastrozole Tablets 1mg 51991-620-33
Anastrozole Tablets 1mg 51991-620-10
Armodafinil 150mg Tablets CIV 51991-323-90
Armodafinil 250mg Tabs (CIV) 51991-324-90
Armodafinil 50mg Tablets CIV 51991-322-90
Cilostazol Tablets 100mg 51991-168-06
Desvenlafaxine Extended-Release Tablets, 100mg 51991-312-33
Desvenlafaxine Extended-Release Tablets, 100mg 51991-312-90
Desvenlafaxine Extended-Release Tablets, 100mg 51991-312-10
Desvenlafaxine Extended-Release Tablets, 50mg 51991-311-33
Desvenlafaxine Extended-Release Tablets, 50mg 51991-311-90
Duloxetine Delayed-release Capsules, USP 20 mg 51991-746-90
Duloxetine Delayed-release Capsules, USP 20 mg 51991-746-05
Duloxetine Delayed-release Capsules, USP 30 mg 51991-747-90
Duloxetine Delayed-release Capsules, USP 30 mg 51991-747-10
Duloxetine Delayed-release Capsules, USP 60 mg 51991-748-90
Duloxetine Delayed-release Capsules, USP 60 mg 51991-748-10
Dutasteride Capsules 0.5mg 51991-749-33
Dutasteride Capsules 0.5mg 51991-749-90
Estradiol / Norethindrone Acetate Tablets 0.5mg/0.1mg (low dose) 51991-623-28
Estradiol / Norethindrone Acetate Tablets 1mg/0.5mg 51991-474-28
Folbic® RF Tablets 51991-616-90
Lansoprazole Delayed-Release Capsules, USP 15mg 51991-771-33
Lansoprazole Delayed-Release Capsules, USP 15mg 51991-771-10
Lansoprazole Delayed-Release Capsules, USP 30mg 51991-772-33
Lansoprazole Delayed-Release Capsules, USP 30mg 51991-772-90
Lansoprazole Delayed-Release Capsules, USP 30mg 51991-772-05
Levetiracetam 100mg/mL Solution 51991-651-16
L-Methylfolate 15mg Caplets 51991-809-90
L-Methylfolate 7.5mg Tablets 51991-808-33
L-Methylfolate 7.5mg Tablets 51991-808-90
L-Methylfolate Forte 15mg Capsules 51991-909-90
L-Methylfolate Forte 7.5mg Capsules 51991-908-90
Mefenamic Acid Capsules, USP 250mg 51991-839-33
Metafolbic™ Plus RF Caplets 51991-911-90
Methylphenidate Hydrochloride Oral Solution 10mg/5mL CII 51991-713-50
Methylphenidate Hydrochloride Oral Solution 5mg/5mL CII 51991-712-50
Nevirapine Tablets, USP 200mg 51991-331-06
Oxcarbazepine Tablets 150mg 51991-292-01
Oxcarbazepine Tablets 150mg 51991-292-05
Oxcarbazepine Tablets 300mg 51991-293-01
Oxcarbazepine Tablets 300mg 51991-293-05
Oxcarbazepine Tablets 600mg 51991-294-01
Oxcarbazepine Tablets 600mg 51991-294-05
Polyethylene Glycol 3350 NF (Powder for Oral Solution) 51991-457-58
Polyethylene Glycol 3350 NF (Powder for Oral Solution) 51991-457-57
Rizatriptan Benzoate Orally Disintegrating Tablets, 10mg 51991-363-78
Rizatriptan Benzoate Orally Disintegrating Tablets, 5mg 51991-362-78
Rizatriptan Benzoate Tablets, 10mg 51991-355-78
Rizatriptan Benzoate Tablets, 5mg 51991-354-78
Terbinafine Tablets, USP 250mg 51991-526-33
Terbinafine Tablets, USP 250mg 51991-526-01
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