{"active_ingredient":["Active ingredient (in each 5 mL teaspoonful) Brompheniramine maleate, USP 1 mg Phenylephrine HCl, USP 2.5 mg"],"ask_doctor":["Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"],"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 not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • to make a child sleepy"],"dosage_and_administration":["Directions • do not take more than 6 doses in any 24-hour period age dose adults and children 12 years and over 4 tsp every 4-6 hours children 6 to under 12 years 2 tsp every 4-6 hours children 4 to under 6 years do not use unless directed by a doctor children under 4 years do not use"],"dosage_and_administration_table":["
agedose
adults and children 12 years and over4 tsp every 4-6 hours
children 6 to under 12 years2 tsp every 4-6 hours
children 4 to under 6 yearsdo not use unless directed by a doctor
children under 4 yearsdo not use
"],"effective_time":"20201203","id":"fae11dd2-aecc-4b33-8281-233f632c9235","inactive_ingredient":["Inactive ingredients citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol"],"indications_and_usage":["Uses • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves these symptoms due to hay fever (allergic rhinitis): • sneezing • itching of the nose or throat • runny nose • itchy, watery eyes • 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."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel Compare to Dimetapp® Cold & Allergy active ingredients For Ages 6 yrs. & Over Children’s Cold & Allergy Elixir Antihistamine (Brompheniramine Maleate) Nasal Decongestant (Phenylephrine HCl) Relieves: Nasal Congestion Sneezing Runny Nose Itchy, Watery Eyes Grape Flavor Alcohol-Free Children's Cold and Allergy Elixir Carton Children's Cold and Allergy Elixir Carton Children's Cold and Allergy Elixir Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine Nasal decongestant"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"bcc8a46c-ba10-4e08-a7ed-d06b4f016847","spl_product_data_elements":["Leader Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BROMPHENIRAMINE MALEATE BROMPHENIRAMINE CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL clear bluish-red"],"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"],"storage_and_handling":["Other information • each teaspoon contains: sodium 2 mg • store at 20°-25°C (68°-77°F) • not a USP elixir"],"version":"3","warnings":["Warnings 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 not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • to make a child sleepy Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • do not use more than directed • drowsiness may occur • 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 • you get nervous, dizzy or sleepless • symptoms do not get better within 7 days or are accompanied by fever 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 • drowsiness may occur • 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"]}