{"active_ingredient":["Active ingredients (in each tablet) Acetaminophen 250 mg Aspirin (NSAID*) 250 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug"],"dosage_and_administration":["Directions • do not use more than directed • drink a full glass of water with each dose Adults and children: (12 years and older) Take 2 Tablets every 6 hours as needed; not more than 8 tablets in 24 hours Children under 12 years: Ask a doctor"],"dosage_and_administration_table":["
Adults and children:(12 years and older) Take 2 Tablets every 6 hours as needed; not more than 8 tablets in 24 hours
Children under 12 years: Ask a doctor
"],"effective_time":"20240228","id":"8987ddc4-ae5c-4a2a-85b4-e73e63d195fc","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyvinyl pyrrolidone, polyethylene glycol, pregelatinized starch, starch 1500, stearic acid, talc"],"indications_and_usage":["Uses temporarily relieves minor aches and pains due to: • headache • muscular aches • arthritis pain • a cold • toothache • premenstrual and menstrual cramps"],"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. 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":["SEDALMEX FORTE"],"generic_name":["ACETAMINOPHEN, ASPIRIN, CAFFEINE"],"is_original_packager":[true],"manufacturer_name":["Belmora LLC"],"nui":["N0000000160","N0000008836","M0001335","N0000175722","N0000175578","N0000008832","N0000175739","N0000175729","N0000175790","M0023046"],"package_ndc":["27854-303-01"],"pharm_class_cs":["Anti-Inflammatory Agents, Non-Steroidal [CS]","Xanthines [CS]"],"pharm_class_epc":["Nonsteroidal Anti-inflammatory Drug [EPC]","Platelet Aggregation Inhibitor [EPC]","Central Nervous System Stimulant [EPC]","Methylxanthine [EPC]"],"pharm_class_moa":["Cyclooxygenase Inhibitors [MoA]"],"pharm_class_pe":["Decreased Prostaglandin Production [PE]","Decreased Platelet Aggregation [PE]","Central Nervous System Stimulation [PE]"],"product_ndc":["27854-303"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308297"],"spl_id":["8987ddc4-ae5c-4a2a-85b4-e73e63d195fc"],"spl_set_id":["33b3508e-4caa-4d05-9b15-cb82a2ee2d4d"],"substance_name":["ACETAMINOPHEN","ASPIRIN","CAFFEINE"],"unii":["362O9ITL9D","R16CO5Y76E","3G6A5W338E"]},"package_label_principal_display_panel":["Packaging image description"],"purpose":["Purpose Pain reliever/fever reducer Pain reliever/fever reducer Pain reliever aid"],"questions":["Questions or comments? 1-888-779-2877 M-F 9AM-5PM EST"],"set_id":"33b3508e-4caa-4d05-9b15-cb82a2ee2d4d","spl_product_data_elements":["SEDALMEX FORTE Acetaminophen, Aspirin, Caffeine ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POVIDONE K30 POLYETHYLENE GLYCOL, UNSPECIFIED STARCH, CORN STEARIC ACID TALC WHITE TO OFF WHITE WITH SPECKS CAPSULE SHAPED BICONVEX S53"],"spl_unclassified_section":["Drug Facts","Fast Headache Relief! KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION Distributed by Belmora LLC , 3033 Wilson BLvd., Suite 700. Arlington, VA 22201, MADE IN INDIA"],"storage_and_handling":["Other information • read all product information before using. Keep box for important information. • store at room temperature between 68°-77°F (20°-25°C) • avoid excessive heat and humidity • tamper evident sealed packets • do not use any opened or torn packets • each tablet contains: Magnesium 0.58 mg"],"version":"1","warnings":["Warnings Reye’s syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. 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. Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock 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 • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • take more or for a longer time than directed • have 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 heart beat. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • If you ever have had an allergic reaction to acetaminophen, aspirin or any other pain relievers/fever reducers Ask a doctor before use if • stomach bleeding warning applies to you • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have a history of stomach problems, such as heartburn • you have asthma • you have liver disease Ask a doctor or pharmacist before use if you are • if you are taking prescription drug for gout, diabetes, or arthritis • taking any other drug, or under a doctor’s care for any serious condition Stop use and ask a doctor if • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days ringing in the ears or loss of hearing occurs painful area is red or swollen any new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding , ask a health care professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."]}