{"adverse_reactions":["ADVERSE REACTIONS There is a potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash). A very serious allergic reaction, called anaphylaxis, to this drug is unlikely, but if it occurs, discontinue the drug and seek immediate medical attention if it occurs. Transient dizziness, drowsiness, and nausea may occur. This can usually be eliminated by reducing the dose. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS, contact ECI Pharmaceuticals, LLC at 954-486-8181 X-109"],"boxed_warning":["Liver warning This product contains acetaminophen. Severe liver damage may occur if a person takes: More than 4,000 mg of acetaminophen in 24 hours With other drugs containing acetaminophen With 3 or more alcoholic drinks every day while using this product."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Isometheptene Mucate is a sympathomimetic amine, acts by constricting dilated cranial and cerebral arterioles, thus reducing the stimuli that lead to vascular headaches. Dichloralphenazone is a mild sedative, reduces the patient's emotional reaction to the pain of both vascular and tension headaches. Acetaminophen raises the threshold to painful stimuli, thus exerting an analgesic effect against all types of headaches."],"contraindications":["CONTRAINDICATIONS Isometheptene Mucate/Dichloralphenazone/Acetaminophen is contraindicated in: Hypersensitivity or intolerance to any component of this product Cardiovascular or cerebrovascular insufficiency, including recent myocardial infarction or stroke Glaucoma, not optimally controlled Severe cases of renal disease Hypertension, not optimally controlled Organic heart disease Peripheral vascular disease Hepatic disease Those patients who are on monoamine-oxidase (mao) inhibitor therapy"],"description":["DESCRIPTION Taken orally, each capsule contains Isometheptene Mucate USP, 65 mg, Dichloralphenazone USP, 100 mg, and Acetaminophen USP, 325 mg. Each capsule also contains Citric Acid, FD&C Blue #1, FD&C Red #40, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc, and Titanium Dioxide. Isometheptene Mucate is a white crystalline powder having a characteristic aromatic odor and bitter taste. It is an unsaturated aliphatic amine with sympathomimetic properties. Isometheptene Mucate is a sympathomimetic amine and its chemical name is 6-Methylamino-2-methylheptene, tetrahydroxyadipic acid. Isometheptene Mucate has the following structural formula. Dichloralphenazone is a white, microcrystalline powder, with slight odor and tastes saline at first, becoming acrid. Dichloralphenazone is a sedative and its chemical name is 1,2-Dihydro-1,5-dimethyl-2-phenyl-3H-pyrazol-3-one, compound with 2,2,2-trichloro-1, 1-ethanediol (1:2). Dichloralphenazone has the following structural formula. Acetaminophen, a non-salicylate, occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Acetaminophen is an analgesic and antipyretic and its chemical name is N -(4-hydroxyphenyl)-. It has the following structural formula: Chemical Structure Chemical Structure Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Take this medication by mouth with or without food as directed by your doctor. FOR RELIEF OF MIGRAINE HEADACHE The usual adult dosage is two capsules at the first sign of the headache as directed by your doctor, 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."],"drug_interactions":["Drug Interactions This drug should not be used with the following medications because very serious interactions may occur: sodium oxybate. Avoid MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur. Consider drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine, phenytoin), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants (e.g., cyclobenzaprine), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone). This medication may interfere with certain laboratory tests (including certain urine glucose tests, urine catecholamine levels, urine 5-HIAA levels), possibly causing false test results."],"effective_time":"20130328","geriatric_use":["Geriatric There is no specific published information comparing use of this combination medicine in the elderly with use in other age groups. Geriatric patients are more likely to have peripheral vascular disease, and are therefore more likely to be adversely affected by peripheral vasoconstriction, than are younger adults. However, isometheptene may be safer for elderly patients than the ergot derivatives used to abort acute vascular headaches. Also, elderly patients are more likely to have age related renal function impairment, which may require caution in patients receiving acetaminophen and isometheptene."],"how_supplied":["HOW SUPPLIED Size '0' Red Capsules with '617' printed in black ink on the cap and body in the following configurations: Bottles of 10 NDC 54868-1514-7 Bottles of 15 NDC 54868-1514-5 Bottles of 30 NDC 54868-1514-3 Bottles of 50 NDC 54868-1514-5 Bottles of 60 NDC 54868-1514-1 Bottles of 90 NDC 54868-1514-6 Bottles of 100 NDC 54868-1514-0 Blister pack of 30 NDC 54868-1514-2 STORAGE Store at controlled room temperature 15°-30°C (59°-86°F) in a dry place in well-closed container. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product."],"how_supplied_table":["
Bottles of 10 NDC 54868-1514-7
Bottles of 15 NDC 54868-1514-5
Bottles of 30 NDC 54868-1514-3
Bottles of 50 NDC 54868-1514-5
Bottles of 60 NDC 54868-1514-1
Bottles of 90 NDC 54868-1514-6
Bottles of 100 NDC 54868-1514-0
Blister pack of 30 NDC 54868-1514-2
"],"id":"a4384ce3-e8ea-409a-92e5-75e77d91d1ff","indications_and_usage":["INDICATIONS AND USAGE For 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."],"nursing_mothers":["Nursing mothers Acetaminophen is excreted into human milk in small concentrations. Metabolites of dichloralphenazone are excreted into human milk. There are no data on the excretion of isometheptene into human milk. Problems in humans have not been documented."],"openfda":{},"overdosage":["OVERDOSAGE If overdose is suspected, contact your local poison control center or emergency room immediately. U.S. residents can call the U.S. national poison hotline at 1-800-222-1222. Symptoms of overdose may include: restlessness, severe drowsiness/dizziness, low body temperature, fast/slow breathing, fast/slow/irregular heartbeat, unresponsiveness."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Isometheptene Mucate, Dichloralphenazone, and Acetaminophen Capsules Rx only 65 mg/100 mg/325 mg No Label Available"],"pediatric_use":["Pediatric use Studies with this medicine have been done only in adult patients, and there is no specific information about its use in children."],"precautions":["PRECAUTIONS Caution should be observed in hypertension, and after recent cardiovascular attacks. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Remember that alcohol may be a cause of headaches. Drug Interactions This drug should not be used with the following medications because very serious interactions may occur: sodium oxybate. Avoid MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur. Consider drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine, phenytoin), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants (e.g., cyclobenzaprine), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone). This medication may interfere with certain laboratory tests (including certain urine glucose tests, urine catecholamine levels, urine 5-HIAA levels), possibly causing false test results. Pregnancy FDA has not assigned a pregnancy category for acetaminophen, dichloralphenazone, or isometheptene. Acetaminophen is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen crosses the placenta and is believed to be safe in pregnancy when used intermittently for short durations. No controlled studies have been done to establish the safety of dichloralphenazone or isometheptene or of their combination with acetaminophen. Acetaminophen/ dichloralphenazone/isometheptene should only be given during pregnancy when need has been clearly established. Nursing mothers Acetaminophen is excreted into human milk in small concentrations. Metabolites of dichloralphenazone are excreted into human milk. There are no data on the excretion of isometheptene into human milk. Problems in humans have not been documented. Pediatric use Studies with this medicine have been done only in adult patients, and there is no specific information about its use in children. Geriatric There is no specific published information comparing use of this combination medicine in the elderly with use in other age groups. Geriatric patients are more likely to have peripheral vascular disease, and are therefore more likely to be adversely affected by peripheral vasoconstriction, than are younger adults. However, isometheptene may be safer for elderly patients than the ergot derivatives used to abort acute vascular headaches. Also, elderly patients are more likely to have age related renal function impairment, which may require caution in patients receiving acetaminophen and isometheptene."],"pregnancy":["Pregnancy FDA has not assigned a pregnancy category for acetaminophen, dichloralphenazone, or isometheptene. Acetaminophen is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen crosses the placenta and is believed to be safe in pregnancy when used intermittently for short durations. No controlled studies have been done to establish the safety of dichloralphenazone or isometheptene or of their combination with acetaminophen. Acetaminophen/ dichloralphenazone/isometheptene should only be given during pregnancy when need has been clearly established."],"set_id":"5fa3e088-d084-4f6d-82a8-ad8d2f423746","spl_product_data_elements":["Isometheptene Mucate/Dichloralphenazone/Acetaminophen ISOMETHEPTENE MUCATE, DICHLORALPHENAZONE, and ACETAMINOPHEN ISOMETHEPTENE MUCATE ISOMETHEPTENE DICHLORALPHENAZONE CHLORAL HYDRATE ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONES STARCH, CORN SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TALC TITANIUM DIOXIDE 617"],"spl_unclassified_section":["CIV CAUTION: Federal law prohibits dispensing without prescription.","Manufactured by: ECI Pharmaceuticals, LLC 5311 NW 35 th Terrace Fort Lauderdale, FL 33309 954-486-8181 The most recent revision of this labeling is 10/2012. Distributed by: Physicians Total Care, Inc. Tulsa, OK 74146"],"storage_and_handling":["STORAGE Store at controlled room temperature 15°-30°C (59°-86°F) in a dry place in well-closed container. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product."],"version":"1"}