{"active_ingredient":["ACTIVE INGREDIENTS (IN EACH 10 ML) Diphenhydramine HCl, USP 12.5 mg Phenylephrine HCl, USP 5 mg"],"ask_doctor":["Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are • taking any other oral nasal decongestant or stimulant • taking sedatives or tranquilizers"],"do_not_use":["Do not use • to sedate a child or to make a child sleepy • 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. • with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["DIRECTIONS • do not take more than 6 doses in any 24-hour period • do not exceed recommended dosage • measure only with dosage cup provided • keep dosage cup with product • ml = milliliter age dose adults and children 12 years and over 20 ml every 4 hours children 6 to under 12 years 10 ml every 4 hours children under 6 years do not use"],"dosage_and_administration_table":["<table width=\"60%\"><col width=\"31%\"/><col width=\"30%\"/><thead><tr><th align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"bottom\"><content styleCode=\"bold\">age</content></th><th align=\"center\" styleCode=\"Rrule Botrule Toprule \" valign=\"bottom\"><content styleCode=\"bold\">dose</content></th></tr></thead><tbody><tr><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>adults and children 12 years and over </paragraph></td><td align=\"center\" styleCode=\"Rrule Toprule Botrule \" valign=\"middle\"><paragraph>20 ml every 4 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>children 6 to under 12 years </paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>10 ml every 4 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>children under 6 years </paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20210722","id":"2dd1a917-b653-471d-8d84-ede7cbd1d6cf","inactive_ingredient":["INACTIVE INGREDIENTS anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose"],"indications_and_usage":["USES • temporarily relieves these symptoms occurring with a cold, hay fever, or other upper respiratory allergies: • nasal congestion • cough • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat"],"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 NDC 0031-2247-13 Children's Dimetapp ® DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant) PHENYLEPHRINE HCl (Nasal Decongestant) Nighttime Cold & Congestion Relieves Nasal Symptoms • Stuffy Nose • Runny Nose • Sneezing Plus Other Symptoms • Itchy, Watery Eyes • Cough For Ages 6 Yrs. & Over 4 FL OZ (118 ml) grape flavor PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["PURPOSES Antihistamine/Cough suppressant Nasal decongestant"],"questions":["QUESTIONS OR COMMENTS? Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675"],"set_id":"df83f907-4695-7257-f503-6e92dc97a2f2","spl_product_data_elements":["CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION diphenhydramine hcl, phenylephrine hcl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE clear, purple liquid"],"spl_unclassified_section":["OTHER INFORMATION • each 10 ml contains: sodium 8 mg • store at 20 -25°C (68 -77°F)"],"stop_use":["Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition."],"version":"9","warnings":["WARNINGS Do not use • to sedate a child or to make a child sleepy • 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. • with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are • taking any other oral nasal decongestant or stimulant • taking sedatives or tranquilizers When using this product • do not use more than directed • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition. 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 • do not use more than directed • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children"]}