{"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":["Do not use for teething in children under 5 years of age"],"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":"20260512","id":"51a73861-dad4-e880-e063-6294a90a9190","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 Uses: temporarily relieves occasional minor irritation and pain associated with: sore throat sore mouth canker sores"],"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. Do not exceed recommended dosage."],"openfda":{"application_number":["M022"],"brand_name":["Cepacol Extra Strength Sore Throat honey lemon"],"generic_name":["BENZOCAINE AND MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Reckitt Benckiser LLC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["63824-732-16"],"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":["63824-732"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["858664","1235472"],"spl_id":["51a73861-dad4-e880-e063-6294a90a9190"],"spl_set_id":["d771095b-7de3-48f3-a125-8bc76e7d1778"],"substance_name":["BENZOCAINE","MENTHOL, UNSPECIFIED FORM"],"unii":["U3RSY48JW5","L7T10EIP3A"],"upc":["0363824730165"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton NDC 63824-732-16 Cēpacol ® EXTRA STRENGTH #1 DOCTOR RECOMMENDED † SORE THROAT Benzocaine 15 mg • Menthol 2.6 mg | Oral Pain Relievers Relieves Sore Throat Pain Fast Acting Maximum Numbing* 16 Lozenges honey lemon flavor *based on amount of benzocaine per dose Label label 2"],"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? 1-866-682-4639"],"recent_major_changes":[""],"set_id":"d771095b-7de3-48f3-a125-8bc76e7d1778","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, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM S Honey-Lemon"],"spl_unclassified_section":["Drug Facts","Dist. by: RB Health (US) 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 at 20-25°C (68-77°F) protect contents from humidity"],"version":"12","warnings":["Warnings Methemoglobinemia warning Use of this product may cause methemoglobinemia, a 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. 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 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, swelling, nausea, or vomiting, consult a doctor promptly. Do not use for teething in children under 5 years of age 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 out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage."]}