{"active_ingredient":["Active Ingredients Active ingredients Purpose Benzocaine, 6.5% ----------------- Anesthesic Menthol, 0.1% ----------------------- Anesthesic Zinc Chloride 0.12% --------------- Astringent Active ingredients"],"do_not_use":["Do not use Do not use for teething in children under 2 years of age for more than 7 days unless directed by a dentist or doctor Do not use"],"dosage_and_administration":["Directions Directions: Adults and children 2 years of age and older apply to affected area gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out use 4 times daily or as directed by dentist or doctor children under 12 years of age should be supervised in the use of the product Children under 2 years of age: do not use Directions"],"effective_time":"20250925","id":"3fa233dc-156d-1e95-e063-6294a90a8bbd","inactive_ingredient":["Inactive Ingredients Inactive ingredients Cetylpyridinium chloride, glycerin, Methylparaben, Proylene Glycol, Propylparaben, Purified Water, Spearmint Flavor and Sucralose. Inactive ingredients"],"indications_and_usage":["Indication and usage section Indication and usage section Adults and children 2 years of age and older apply to affected area gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out use 4 times daily or as directed by dentist or doctor children under 12 years of age should be supervised in the use of the product Children under 2 years of age: do not use indication an user"],"keep_out_of_reach_of_children":["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 Keep out of reach of children"],"openfda":{"application_number":["M022"],"brand_name":["Giltuss Bucalsep"],"generic_name":["BENZOCAINE, MENTHOL, ZINC CHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Dextrum Laboratories Inc."],"nui":["N0000175530","N0000175529","N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["65852-015-01"],"pharm_class_cs":["Allergens [CS]"],"pharm_class_epc":["Copper Absorption Inhibitor [EPC]","Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Decreased Copper Ion Absorption [PE]","Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"product_ndc":["65852-015"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL","TOPICAL"],"spl_id":["3fa233dc-156d-1e95-e063-6294a90a8bbd"],"spl_set_id":["3fa233dc-156c-1e95-e063-6294a90a8bbd"],"substance_name":["ZINC CATION","BENZOCAINE","MENTHOL"],"unii":["13S1S8SF37","U3RSY48JW5","L7T10EIP3A"]},"other_safety_information":["Other information Other information Store at room temperature Other Information"],"package_label_principal_display_panel":["NDC: 58552-135-01 Alcohol free Oral Spray Giltuss Bucalsep Sore, Throat, Oral astringent 1 floz (30 mL) Alcohol free, sugar free, dye free Spearmint flavor Active ingredients"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding If pregnant or breastfeeding, ask a health professional before use If pregnant"],"purpose":["Uses Uses temporary relieves pain due to the following mouth and gum irritations sore mouth and throat canker sores minor dental procedures dentures or orthodontic appliance Uses"],"questions":["Questions or comments? Questions or Comments? Questions or comments? Call 1-787-848-9114, Monday-Friday 9AM – 5PM EST Call your doctor for medical advice in the event of side effects. Questions"],"set_id":"3fa233dc-156c-1e95-e063-6294a90a8bbd","spl_product_data_elements":["Giltuss Bucalsep Benzocaine, Menthol, Zinc chloride ZINC CATION ZINC CATION PROPYLPARABEN BENZOCAINE BENZOCAINE CETYLPYRIDINIUM CHLORIDE MENTHOL MENTHOL GLYCERIN METHYLPARABEN WATER PROPYLENE GLYCOL SUCRALOSE"],"stop_use":["Stop use and ask a doctor if Stop use and ask a doctor if Sore throat is severe, persist for more than 2 days, is accompanied, or followed by fever, headache, rash,nausea or vomiting Symptoms do not improve in 7 days irritation, pain or redness persist or worsen swelling, rash or fever develops Stop use and ask a doctor Stop use and ask"],"version":"1","warnings":["Warnings Warnings Do not use IN OR NEAR THE EYES. In the event of accidental contact with the eyes, flush immediately and continuosly for 10 minutes. Seek immediate medical attention if pain or irritations persists. this product for more than 7 days unless directed by a doctor or a dentist Methemoglobinemia Warning: use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before.Stopo use and seek immediate medical attention if you or a child in your care develops: pale, gray or blue colored skin ( cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetic Allergy alert Warnings"],"when_using":["When using this product When using this product do not exceed recommended dosage avoid contact with eyes. In case of eye contact, rinse with water When using this product"]}