{"active_ingredient":["Active ingredients (in each 5 mL) Purpose Brompheniramine Maleate 4 mg Antihistamine Dextromethorphan HBr 15 mg Antitussive Phenylephrine HCl 7.5 mg Nasal Decongestant"],"active_ingredient_table":["<table width=\"50%\" border=\"2\"> <caption/> <tbody> <tr> <td> <content styleCode=\"bold\">Active ingredients (in each 5 mL)</content> </td> <td> <content styleCode=\"bold\">Purpose</content> </td> </tr> <tr> <td> Brompheniramine Maleate 4 mg</td> <td>Antihistamine </td> </tr> <tr> <td> Dextromethorphan HBr 15 mg</td> <td>Antitussive</td> </tr> <tr> <td> Phenylephrine HCl 7.5 mg</td> <td>Nasal Decongestant</td> </tr> </tbody> </table>"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers if cough persist for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistant headache; a persistant cough may be a sign of a serious condition."],"do_not_use":["DO NOT USE if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product unless directed by a doctor for persistant or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), heart disease, high blood pressure, thyroid disease, diabetes"],"dosage_and_administration":["Directions Do not exeed recommended dosage. Use calibrated measuring device for administering the drug to a child. Adult and children 12 years of age and over: 1 teaspoonful (5mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor. Children inder 6 years of age: Consult a doctor."],"dosage_and_administration_table":["<table width=\"70%\" border=\"2\"> <caption/> <tbody> <tr> <td styleCode=\"Lrule Rrule Toprule Botrule\">Adult and children 12 years of age and over:</td> <td styleCode=\"Lrule Rrule Toprule Botrule\">1 teaspoonful (5mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor.</td> </tr> <tr> <td styleCode=\"Lrule Rrule Toprule Botrule\"> <paragraph>Children 6 to under 12 years of age:</paragraph> </td> <td styleCode=\"Lrule Rrule Toprule Botrule\">1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor.</td> </tr> <tr> <td styleCode=\"Lrule Rrule Toprule Botrule\">Children inder 6 years of age:</td> <td styleCode=\"Lrule Rrule Toprule Botrule\">Consult a doctor.</td> </tr> </tbody> </table>"],"effective_time":"20170819","id":"5727e5bc-32e3-4af4-95bd-003aa1036e5f","inactive_ingredient":["Inactive Ingredients Citric Acid, Glycerin, Purified Water, Sodium Benzoate, Sodium Saccharin, Sorbitol, Strawberry Flavor."],"indications_and_usage":["Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and brochial irritation runny nose sneezing itching of the nose or throat ithcy, watery eyes nasal congestion reduces swelling of nasal passages"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately."],"openfda":{},"package_label_principal_display_panel":["35573-321-16 RelCof™ DM Antihistamine•Antitussive•Nasal Decongestant Each teaspoonful (5 mL) Contains: Brompheniramine Maleate....................4 mg Dextromethorphan HBr........................15 mg Phenylephrine HCl...............................7.5 mg Alcohol•Dye Free•Sugar Free Strawberry Flavor Burel Pharmaceuticals Tamper evident by foil seal uder cap. Do not use if foil seal is broken or missing. 16 fl oz (473 ml) OTC MONOGRAPH FINAL, 21 CFR PART 341 RelCof DM"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each 5 mL) Purpose Brompheniramine Maleate 4 mg Antihistamine Dextromethorphan HBr 15 mg Antitussive Phenylephrine HCl 7.5 mg Nasal Decongestant"],"purpose_table":["<table width=\"50%\" border=\"2\"> <caption/> <tbody> <tr> <td> <content styleCode=\"bold\">Active ingredients (in each 5 mL)</content> </td> <td> <content styleCode=\"bold\">Purpose</content> </td> </tr> <tr> <td> Brompheniramine Maleate 4 mg</td> <td>Antihistamine </td> </tr> <tr> <td> Dextromethorphan HBr 15 mg</td> <td>Antitussive</td> </tr> <tr> <td> Phenylephrine HCl 7.5 mg</td> <td>Nasal Decongestant</td> </tr> </tbody> </table>"],"questions":["Questions? Comment? To report a serious adverse event or obtain product information, contact 1-601-706-9819"],"set_id":"565c68a4-f01b-46c0-b9de-274246935b9c","spl_product_data_elements":["RelCof DM Brompheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl BROMPHENIRAMINE MALEATE BROMPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE GLYCERIN WATER SODIUM BENZOATE SACCHARIN SODIUM SORBITOL"],"spl_unclassified_section":["Manufactured For: Burel Pharmaceuticals, Inc. 199 Interstate Dr. • Richland, MS 39218"],"storage_and_handling":["Other Information Store at 20° - 25°C (68°-77°F); excursions permitted to 15° - 30°C (59°-86°F)."],"version":"2","warnings":["WARNINGS Do not exceed the recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. May cause excitability especially in children. Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers if cough persist for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistant headache; a persistant cough may be a sign of a serious condition. When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect be carefull when driving a motor vehicle or operating machinery Questions? Comment? To report a serious adverse event or obtain product information, contact 1-601-706-9819 DO NOT USE if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product unless directed by a doctor for persistant or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), heart disease, high blood pressure, thyroid disease, diabetes If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately."],"when_using":["When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect be carefull when driving a motor vehicle or operating machinery"]}