{"active_ingredient":["Active ingredients (in each 5 mL teaspoonful) Purpose Brompheniramine Maleate 4 mg Antihistamine Dextromethorphan Hydrobromide 15 mg Antitussive Phenylephrine Hydrochloride 7.5 mg Nasal Decongestant"],"active_ingredient_table":["<table width=\"70%\"> <col width=\"50%\" align=\"left\" valign=\"top\"/> <col width=\"50%\" align=\"right\" valign=\"top\"/> <thead> <tr> <th> <content styleCode=\"italics\">Active ingredients (in each 5 mL teaspoonful)</content> </th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr> <td>Brompheniramine Maleate 4 mg</td> <td valign=\"bottom\">Antihistamine</td> </tr> <tr> <td>Dextromethorphan Hydrobromide 15 mg</td> <td valign=\"bottom\">Antitussive</td> </tr> <tr> <td>Phenylephrine Hydrochloride 7.5 mg</td> <td valign=\"bottom\">Nasal Decongestant</td> </tr> </tbody> </table>"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."],"do_not_use":["Do not use this product 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 not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours 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 Children under 6 years of age: Consult a doctor."],"dosage_and_administration_table":["<table width=\"55%\" styleCode=\"Noautorules\"> <col width=\"40%\" align=\"left\" valign=\"top\"/> <col width=\"60%\" align=\"left\" valign=\"top\"/> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule Toprule\">Adults and children 12 years of age and over:</td> <td styleCode=\"Toprule\">1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule\">Children 6 to under 12 years of age:</td> <td>1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours</td> </tr> <tr> <td styleCode=\"Rrule\">Children under 6 years of age:</td> <td>Consult a doctor.</td> </tr> </tbody> </table>"],"effective_time":"20180222","id":"c43fc0f0-7471-409b-92f9-9fdf4e1b1b31","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: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation 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 right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 75834-060-16 Niva-Hist DM™ Liquid Antihistamine • Antitussive Nasal Decongestant Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg Dextromethorphan HBr 15 mg Phenylephrine HCl 7.5 mg Strawberry Flavor SUGAR FREE / ALCOHOL FREE DYE FREE NIVAGEN PHARMACEUTICALS 16 fl oz. (473 mL) PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each 5 mL teaspoonful) Purpose Brompheniramine Maleate 4 mg Antihistamine Dextromethorphan Hydrobromide 15 mg Antitussive Phenylephrine Hydrochloride 7.5 mg Nasal Decongestant"],"purpose_table":["<table width=\"70%\"> <col width=\"50%\" align=\"left\" valign=\"top\"/> <col width=\"50%\" align=\"right\" valign=\"top\"/> <thead> <tr> <th> <content styleCode=\"italics\">Active ingredients (in each 5 mL teaspoonful)</content> </th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr> <td>Brompheniramine Maleate 4 mg</td> <td valign=\"bottom\">Antihistamine</td> </tr> <tr> <td>Dextromethorphan Hydrobromide 15 mg</td> <td valign=\"bottom\">Antitussive</td> </tr> <tr> <td>Phenylephrine Hydrochloride 7.5 mg</td> <td valign=\"bottom\">Nasal Decongestant</td> </tr> </tbody> </table>"],"questions":["Questions? Comments? Serious side effects associated with use of this product may be reported to this number. Call 1-877-977-0687 Mon. - Fri. (8 a.m. to 5 p.m. CST)."],"set_id":"ff0860ca-0c2b-4311-b903-bcfdb8604f1d","spl_product_data_elements":["Niva-Hist DM BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE BROMPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CITRIC ACID MONOHYDRATE GLYCERIN WATER SODIUM BENZOATE SACCHARIN SODIUM SORBITOL"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur"],"storage_and_handling":["Other information Store at 59° - 86°F (15° - 30°C)"],"version":"2","warnings":["Warnings Do not exceed recommended dosage. Do not use this product 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 not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. 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 careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur 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 right away."],"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 careful when driving a motor vehicle or operating machinery"]}