{"active_ingredient":["Active ingredients (in each lozenge) Purposes Benzocaine 15 mg Oral pain reliever Menthol 2.6 mg Oral pain reliever"],"active_ingredient_table":["| Active ingredients (in each lozenge) | Purposes |
|---|
| Benzocaine 15 mg | Oral pain reliever |
| Menthol 2.6 mg | Oral pain reliever |
"],"do_not_use":["Allergy alert Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or any other 'caine' anesthetics."],"dosage_and_administration":["Directions adults and children 5 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist. children under 5 years of age: do not use"],"effective_time":"20250624","id":"38526501-fa87-56f9-e063-6394a90a7159","inactive_ingredient":["Inactive ingredients D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose"],"indications_and_usage":["Uses Temporary relief of occasional sore throat sore mouth minor mouth irritation pain associated with canker sores"],"keep_out_of_reach_of_children":["Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M"],"brand_name":["Cepacol Extra Strength Sore Throat honey lemon"],"generic_name":["BENZOCAINE AND MENTHOL"],"manufacturer_name":["ATLANTIC BIOLOGICALS CORP."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"original_packager_product_ndc":["63824-732"],"package_ndc":["17856-0732-2","17856-0732-1"],"pharm_class_cs":["Allergens [CS]"],"pharm_class_epc":["Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"product_ndc":["17856-0732"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["858664","1235472"],"spl_id":["38526501-fa87-56f9-e063-6394a90a7159"],"spl_set_id":["08160ced-e19b-443e-ab16-0d3e4ae8a8ab"],"substance_name":["BENZOCAINE","MENTHOL"],"unii":["U3RSY48JW5","L7T10EIP3A"]},"package_label_principal_display_panel":["CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE 1"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each lozenge) Purposes Benzocaine 15 mg Oral pain reliever Menthol 2.6 mg Oral pain reliever"],"purpose_table":["| Active ingredients (in each lozenge) | Purposes |
|---|
| Benzocaine 15 mg | Oral pain reliever |
| Menthol 2.6 mg | Oral pain reliever |
"],"questions":["Questions? Call 1-866-682-4639 You may also report side effects to this phone number."],"set_id":"08160ced-e19b-443e-ab16-0d3e4ae8a8ab","spl_product_data_elements":["Cepacol Extra Strength Sore Throat honey lemon Benzocaine and Menthol D&C YELLOW NO. 10 FD&C YELLOW NO. 6 ISOMALT MALTITOL PROPYLENE GLYCOL WATER SODIUM BICARBONATE SUCRALOSE BENZOCAINE BENZOCAINE MENTHOL MENTHOL S Honey-Lemon"],"spl_unclassified_section":["Drug Facts","Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in England"],"stop_use":["Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops"],"storage_and_handling":["Other information store between 20-25°C (68-77°F) protect contents from humidity"],"version":"7","warnings":["Warnings 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. Stop 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 any other 'caine' anesthetics. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops If pregnant or breast-feeding, ask a health professional before use. Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage."]}