{"active_ingredient":["Active ingredients and Purposes Active ingredients Purposes Acetaminophen 500 mg................... Pain reliever/fever reducer Caffeine 65 mg................................. Pain reliever aid"],"active_ingredient_table":["
Active ingredientsPurposes
Acetaminophen 500 mg...................Pain reliever/fever reducer
Caffeine 65 mg.................................Pain reliever aid
"],"ask_doctor":["Ask a doctor before use if you have liver disease"],"ask_doctor_or_pharmacist":["Ask a doctor before use if you are taking the blood thinning drug warfarin"],"do_not_use":["Do not use with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if allergic to any of the ingredients in this product on children under 12 years of age"],"dosage_and_administration":["Directions do not take more than directed (see OVERDOSE WARNING) adults and children 12 years of age and older: take 2 tablets, every 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours children under 12 years of age: do not use"],"effective_time":"20240919","id":"227ba7f7-a051-50ad-e063-6394a90a74d6","inactive_ingredient":["Inactive ingredients croscarmellose sodium, microcrystalline cellulose 101, povidone k30, silicon dioxide, stearic acid, water"],"indications_and_usage":["Uses For the temporary relief of minor aches and pains due to: toothache headache and to reduce fever"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN. OVERDOSE WARNING: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M013"],"brand_name":["DoloDent Toothache For adults"],"generic_name":["ACETAMINOPHEN, CAFFEINE"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"nui":["N0000175739","N0000175729","N0000175790","M0023046"],"package_ndc":["55758-435-24"],"pharm_class_cs":["Xanthines [CS]"],"pharm_class_epc":["Central Nervous System Stimulant [EPC]","Methylxanthine [EPC]"],"pharm_class_pe":["Central Nervous System Stimulation [PE]"],"product_ndc":["55758-435"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["307686"],"spl_id":["227ba7f7-a051-50ad-e063-6394a90a74d6"],"spl_set_id":["1e7a0c06-ad3c-b94f-e063-6394a90abab1"],"substance_name":["CAFFEINE","ACETAMINOPHEN"],"unii":["3G6A5W338E","362O9ITL9D"]},"package_label_principal_display_panel":["Principal Display Panel Dolodent PDP"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use."],"purpose":["Active ingredients Purposes Acetaminophen 500 mg................... Pain reliever/fever reducer Caffeine 65 mg................................. Pain reliever aid"],"purpose_table":["
Active ingredientsPurposes
Acetaminophen 500 mg...................Pain reliever/fever reducer
Caffeine 65 mg.................................Pain reliever aid
"],"questions":["Questions? +1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com"],"set_id":"1e7a0c06-ad3c-b94f-e063-6394a90abab1","spl_product_data_elements":["DoloDent Toothache For adults Acetaminophen, Caffeine CROSCARMELLOSE SODIUM CROSCARMELLOSE POVIDONE K30 MICROCRYSTALLINE CELLULOSE 101 STEARIC ACID SILICON DIOXIDE WATER CAFFEINE CAFFEINE ACETAMINOPHEN ACETAMINOPHEN (Capsule-Shaped Tablet) A2"],"spl_unclassified_section":["Drug Facts Drug Facts","Distributed by / Distribuido por: PHARMADEL LLC New Castle, DE, 19720"],"stop_use":["Stop use and ask a doctor or dentist if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear"],"storage_and_handling":["Other information store between 68°-77°F (20°-25°C)"],"version":"5","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours , which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash. If a skin reaction occurs, stop use and seek medical help right away. Caffeine: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine -containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. Do not use with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if allergic to any of the ingredients in this product on children under 12 years of age Ask a doctor before use if you have liver disease Ask a doctor before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor or dentist if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear If pregnant or breastfeeding, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. OVERDOSE WARNING: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."]}