{"active_ingredient":["Active ingredients (in each 10 ml) Brompheniramine maleate, 2 mg Dextromethorphan HBr, 10 mg Phenylephrine HCl , 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 persistent or chronic cough that lasts such 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."],"dosage_and_administration":["Directions ▪ do not take more than 6 doses in any 24-hour period ▪ 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":["
agedose
adults and children 12 years and over 20 ml every 4 hours
children 6 to under 12 years10 ml every 4 hours
children under 6 yearsdo not use
"],"effective_time":"20230916","id":"5ce66097-4718-4cb5-872a-a7d4816773b8","inactive_ingredient":["Inactive ingredients anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, artificial flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose"],"indications_and_usage":["Uses ▪ temporarily relieves: ▪ Nasal congestion ▪ runny nose ▪ cough ▪ sneezing ▪ itchy, watery eyes due to hay fever ▪ itching of the nose or throat ▪ temporarily restores freer breathing through the nose"],"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 at 1-800-222-1222."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Compare to the active ingredients in Children’s Dimetapp® Cold & Cough* NDC 55319-645-04 Children's Cold & Cough Brompheniramine maleate (Antihistamine) Dextromethorphan HBr (Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) Relieves Nasal Symptoms • Stuffy Nose • Runny Nose • Sneezing Plus Other Symptoms • Itchy, Watery Eyes • Cough For Ages 6 Years and Over Grape Flavor Naturally and Artificially Flavored 4 FL OZ (118 ml) Distributed by: *This product is not distributed by Foundation Consumer Brands, LLC, the distributor of Children’s Dimetapp® Cold & Cough*. Children's Cold & Cough 4 FL OZ 118 mL"],"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? 1-866-467-2748"],"set_id":"cead7f84-382c-450c-9fcd-91cd3893db75","spl_product_data_elements":["CHILDRENS DIMETAPP COLD AND COUGH brompheniramine maleate, dextromethorphan HBr, phenylephrine HCl BROMPHENIRAMINE MALEATE BROMPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL PROPYL GALLATE WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE purple liquid grape flavor and odor"],"spl_unclassified_section":["Other information ▪ each 10 ml contains: sodium 6 mg ▪ store at room temperature."],"stop_use":["Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occurs • symptoms do not get better within 7 days or are accompanied by fever, rash, or persistent headache. These could be signs of a serious condition."],"version":"2","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. 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 persistent or chronic cough that lasts such 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 ▪ may cause marked drowsiness ▪ avoid alcoholic beverages ▪ 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 • nervousness, dizziness, or sleeplessness occurs • symptoms do not get better within 7 days or are 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 at 1-800-222-1222."],"when_using":["When using this product ▪ do not use more than directed ▪ may cause marked drowsiness ▪ avoid alcoholic beverages ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ be careful when driving a motor vehicle or operating machinery ▪ excitability may occur, especially in children"]}