{"adverse_reactions":["Adverse Reactions: Hypersensitive patients have shown rash and transient dizziness; this can be eliminated by reducing dosage."],"boxed_warning":["*Based on a review of this drug (isometheptene mucate) by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the other indication as \"possibly\" effective in the treatment of migraine headache. Final classification of the less-than-effective indication requires further investigation."],"contraindications":["Contraindications: MigraTen® is contraindicated in glaucoma and/or severe cases of renal disease, hypertension, organic heart disease, hepatic disease and in those patients who are on monoamine-oxidase (MAO) inhibitor therapy."],"description":["Description: Each green and yellow capsule contains Isometheptene Mucate 65 mg, Caffeine 100 mg, and Acetaminophen 325 mg. Inactive ingredients: Croscarmellose Sodium, D&C Yellow #10 lake, FD&C Blue #1 Lake, FD&C Yellow #6 Lake, Gelatin, Polyvinylpyrrolidone, Pregelatinized Starch, Silica, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide. Isometheptene Mucate is a white crystalline powder having a characteristic aromatic and bitter taste. It is an unsaturated aliphatic amine with sympathomimetic properties. Caffeine is a white crystalline powder with a bitter taste. Acetaminophen, a non-salicylate, occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste."],"dosage_and_administration":["Dosage and Administration: For RELIEF of MIGRAINE HEADACHE the usual adult dosage is two capsules at once, followed by one capsule every hour until relieved, up to 5 capsules within a twelve-hour period. For RELIEF of TENSION HEADACHE the usual adult dosage is one or two capsules every four hours, up to 8 capsules a day."],"effective_time":"20100510","id":"488670e8-c373-4597-ae52-eab3d7736eb4","indications_and_usage":["Indications: For the relief of tension and vascular headaches*. *Based on a review of this drug (isometheptene mucate) by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the other indication as \"possibly\" effective in the treatment of migraine headache. Final classification of the less-than-effective indication requires further investigation."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel 100 Capsules, NDC 66663-112-01 MigraTen® Migraine Tension Headache Migraine* and Tension Headache Rx Only Dist. by: AZUR PHARMA, INC. 1818 Market Street, Suite 2350 Philadelphia, PA 19103 www.azurpharma.com Mfg. by: Contract Pharmacal Corp. Hauppauge, NY 11788 Bottle Label Principal Display Panel - Bottle"],"precautions":["Precautions: Caution should be observed in hypertension, peripheral vascular disease and after recent cardio-vascular attacks."],"set_id":"488670e8-c373-4597-ae52-eab3d7736eb4","spl_product_data_elements":["MigraTen Acetaminophen, Isometheptene Mucate, and Caffeine ISOMETHEPTENE MUCATE ISOMETHEPTENE MUCATE CAFFEINE CAFFEINE ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C YELLOW NO. 6 GELATIN POVIDONE K30 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE P007"],"spl_unclassified_section":["Actions: Isometheptene Mucate, a sympathomimetic amine, and Caffeine act by constricting dilated cranial and cerebral arterioles, thus reducing the stimuli that lead to vascular headache. Acetaminophen raises the threshold to painful stimuli, thus exerting an analgesic effect against all types of headaches. Keep this and all medications out of the reach of children."],"storage_and_handling":["How Supplied: Green and yellow capsules imprinted with P-007 in Black letters. Bottles of 100 capsules, NDC 66663-112-01. Store at a controlled room temperature 15° - 30° C (59° - 86° F) in a dry place. To report a serious adverse event or obtain product information, contact (800) 890-3098."],"version":"1"}