{"active_ingredient":["Active ingredients (in each 10 ml) Purposes Brompheniramine maleate, USP 2 mg Antihistamine Dextromethorphan HBr, USP 10 mg Cough Suppressant Phenylephrine HCl, USP 5 mg Nasal decongestant"],"active_ingredient_table":["
Active ingredients (in each 10 ml)Purposes
Brompheniramine maleate, USP 2 mgAntihistamine
Dextromethorphan HBr, USP 10 mgCough Suppressant
Phenylephrine HCl, USP 5 mgNasal decongestant
"],"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 a 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) (certaindrugs 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 dosing 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 over20 mL every 4 hours
children 6 to under 12 years10 mL every 4 hours
children under 6 yearsdo not use
"],"effective_time":"20241230","id":"2a813b38-77a1-e4a0-e063-6394a90a9303","inactive_ingredient":["Inactive ingredients citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose"],"indications_and_usage":["Uses temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes 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."],"openfda":{"application_number":["M012"],"brand_name":["Pediacare Childrens Cough and Cold Grape"],"generic_name":["BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH"],"package_ndc":["52412-920-01"],"product_ndc":["52412-920"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1090463"],"spl_id":["2a813b38-77a1-e4a0-e063-6394a90a9303"],"spl_set_id":["fabafdc1-9dd8-4258-af49-bab1e29ad109"],"substance_name":["BROMPHENIRAMINE MALEATE","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["IXA7C9ZN03","9D2RTI9KYH","04JA59TNSJ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton Fast Acting Pedia Care ® 100% dedicated to kids™ 6 Years & Up COUGH & COLD Relieves: Stuffy, Runny Nose Itchy, Watery Eyes Sneezing Cough Brompheniramine maleate - Antihistamine (2 mg per 10 mL) Phenylephrine HCl - Nasal decongestant (5 mg per 10 mL) Dextromethorphan HBr - Cough suppressant (10 mg per 10 mL) Alcohol Free Grape Flavor 4 FL OZ (118 mL) PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each 10 ml) Purposes Brompheniramine maleate, USP 2 mg Antihistamine Dextromethorphan HBr, USP 10 mg Cough Suppressant Phenylephrine HCl, USP 5 mg Nasal decongestant"],"purpose_table":["
Active ingredients (in each 10 ml)Purposes
Brompheniramine maleate, USP 2 mgAntihistamine
Dextromethorphan HBr, USP 10 mgCough Suppressant
Phenylephrine HCl, USP 5 mgNasal decongestant
"],"set_id":"fabafdc1-9dd8-4258-af49-bab1e29ad109","spl_product_data_elements":["Pediacare Childrens Cough and Cold Grape BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE BROMPHENIRAMINE MALEATE BROMPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"spl_unclassified_section":["Drug Facts","Distributed by CrossingWell Consumer Health PO Box 440 Cornwall, NY 12518"],"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."],"storage_and_handling":["Other information store at 20-25°C (68-77°F)"],"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) (certaindrugs 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 a 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 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 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"]}