{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 65 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin"],"do_not_use":["Do not use if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist."],"dosage_and_administration":["Directions do not use more than directed adults and children 12 years and over : take 2 caplets every 6 hours; not more than 6 caplets in 24 hours children under 12 years : ask a doctor"],"effective_time":"20250613","id":"377780a5-9495-2c39-e063-6294a90ac8b2","inactive_ingredient":["Inactive ingredients Colloidal silicon dioxide, croscarmellose sodium, D&C red no. 27, FD&C blue no. 2, FD&C yellow no. 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves minor aches and pain due to: headache muscular aches"],"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 at 1-800-222-1222. Quick 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":["DRX CHOICE Tension Headache"],"generic_name":["ACETAMINOPHEN, CAFFEINE"],"is_original_packager":[true],"manufacturer_name":["Raritan Pharmaceuticals Inc."],"nui":["N0000175739","N0000175729","N0000175790","M0023046"],"package_ndc":["68163-506-15"],"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":["68163-506"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["307686"],"spl_id":["377780a5-9495-2c39-e063-6294a90ac8b2"],"spl_set_id":["8a5cb38b-669d-4177-b33b-d73c7ef48d18"],"substance_name":["ACETAMINOPHEN","CAFFEINE"],"unii":["362O9ITL9D","3G6A5W338E"],"upc":["0368163065152"]},"package_label_principal_display_panel":["Principal Display Panel Compare to Excedrin® Tension Headache active ingredients * NDC 68163-506-15 DRx Choice tension headache relief ASPIRIN-FREE Acetaminophen 500 mg, Caffeine 65 mg Pain Reliever / Pain Reliever Aid ACTUAL SIZE 15 CAPLETS TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING. IMPORTANT: Keep this carton for future reference on full labeling. Distributed by: Raritan Pharmaceuticals 8 Joanna Court East Brunswick, NJ 08816 *This product is not manufactured or distributed by Haleon CH Sarl., owner of the registered trademark Excedrin Tension Headache. DRx Choice Tension Headache Relief 15 caplets"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever Pain reliever aid"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"8a5cb38b-669d-4177-b33b-d73c7ef48d18","spl_product_data_elements":["DRX CHOICE Tension Headache Acetaminophen, Caffeine SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C RED NO. 27 ALUMINUM LAKE FD&C BLUE NO. 2 FD&C YELLOW NO. 6 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED EICOSYL POVIDONE STARCH, CORN STEARIC ACID TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN CAFFEINE CAFFEINE Caplet RP065"],"spl_unclassified_section":["Other information store at room temperature close cap tightly after use read all product information before using."],"stop_use":["Stop use and ask a doctor if any new symptoms occur painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days These could be signs of a serious condition."],"version":"1","warnings":["Warnings 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. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Caffeine warning: 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 if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if any new symptoms occur painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days 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 at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.","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.","Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product","Caffeine warning: 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."]}