{"active_ingredient":["Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr, USP 5 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant"],"active_ingredient_table":["
Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr, USP 5 mgCough suppressant
Guaifenesin, USP 100 mgExpectorant
"],"ask_doctor":["Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema"],"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."],"dosage_and_administration":["Directions do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product mL=milliliter AGE DOSE children under 4 years do not use children 4 to under 6 years 5 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours adults and children 12 years and over 20 mL every 4 hours"],"dosage_and_administration_table":["
AGEDOSE
children under 4 yearsdo not use
children 4 to under 6 years5 mL every 4 hours
children 6 to under 12 years10 mL every 4 hours
adults and children 12 years and over20 mL every 4 hours
"],"effective_time":"20241230","id":"2a815f27-d222-bc77-e063-6294a90a5f7a","inactive_ingredient":["Inactive ingredients acesulfame potassium, citric acid anhydrous, glycerin, flavor, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin"],"indications_and_usage":["Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes"],"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 Congestion Grape"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["52412-992-01"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["52412-992"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020138"],"spl_id":["2a815f27-d222-bc77-e063-6294a90a5f7a"],"spl_set_id":["9576723b-748c-45e7-bc0d-cc109b9f6735"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"],"upc":["0030103092053"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton Fast Acting Pedia Care ® 100% dedicated to kids™ 4 Years & Up COUGH & CONGESTION Relieves: Congestion & Mucus Cough Dextromethorphan HBr, USP (5 mg per 5 mL) Guaifenesin, USP (100 mg per 5 mL) Non-Drowsy 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 5 mL) Purposes Dextromethorphan HBr, USP 5 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant"],"purpose_table":["
Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr, USP 5 mgCough suppressant
Guaifenesin, USP 100 mgExpectorant
"],"set_id":"9576723b-748c-45e7-bc0d-cc109b9f6735","spl_product_data_elements":["Pediacare Childrens Cough and Congestion Grape DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN ACESULFAME POTASSIUM CITRIC ACID MONOHYDRATE GLYCERIN MENTHOL, UNSPECIFIED FORM POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SACCHARIN SODIUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN"],"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 cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition."],"storage_and_handling":["Other information store at 20-25°C (68-77°F) do not refrigerate alcohol-free"],"version":"2","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. Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant 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."]}