{"active_ingredient":["Active ingredients and Purposes . Active ingredients Purposes Acetaminophen 250 mg................... Pain reliever Aspirin 250 mg (NSAID*) ................ Pain reliever Caffeine 65 mg................................. Pain reliever aid * nonsteroidal anti-inflammatory drug"],"active_ingredient_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purposes</content></content></td></tr><tr><td>Acetaminophen 250 mg...................</td><td>Pain reliever</td></tr><tr><td>Aspirin 250 mg <content styleCode=\"bold\">(NSAID*)</content>................ </td><td>Pain reliever</td></tr><tr><td>Caffeine 65 mg.................................</td><td>Pain reliever aid</td></tr></tbody></table>"],"ask_doctor":["Ask a doctor before use if you have liver disease you have asthma stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition"],"do_not_use":["Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer 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 take more than directed (See WARNINGS ) adults and children 12 years of age and older: take two (2) tablets every 6 hours with a full glass of water. Do not take more than 8 tablets in 24 hours. children under 12 years of age: consult a doctor"],"effective_time":"20251217","id":"462857bf-e00b-287d-e063-6294a90aa93b","inactive_ingredient":["Inactive ingredients corn starch, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone k30, silicon dioxide, stearic acid, talc, water"],"indications_and_usage":["Uses Temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps and bloating"],"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 (1-800-222-1222). 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":["Dolex Forte"],"generic_name":["ACETAMINOPHEN, ASPIRIN, CAFFEINE"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"nui":["N0000000160","N0000008836","M0001335","N0000175722","N0000175578","N0000008832","N0000175739","N0000175729","N0000175790","M0023046"],"package_ndc":["55758-509-24","55758-509-02","55758-509-50"],"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":["55758-509"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308297"],"spl_id":["462857bf-e00b-287d-e063-6294a90aa93b"],"spl_set_id":["3c2d90fc-130d-476c-e063-6294a90a8c15"],"substance_name":["ACETAMINOPHEN","ASPIRIN","CAFFEINE"],"unii":["362O9ITL9D","R16CO5Y76E","3G6A5W338E"]},"package_label_principal_display_panel":["Principal Display Panel PDP Dolex Forte"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery."],"purpose":["Active ingredients Purposes Acetaminophen 250 mg................... Pain reliever Aspirin 250 mg (NSAID*) ................ Pain reliever Caffeine 65 mg................................. Pain reliever aid * nonsteroidal anti-inflammatory drug"],"purpose_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purposes</content></content></td></tr><tr><td>Acetaminophen 250 mg...................</td><td>Pain reliever</td></tr><tr><td>Aspirin 250 mg <content styleCode=\"bold\">(NSAID*)</content>................ </td><td>Pain reliever</td></tr><tr><td>Caffeine 65 mg.................................</td><td>Pain reliever aid</td></tr></tbody></table>"],"set_id":"3c2d90fc-130d-476c-e063-6294a90a8c15","spl_product_data_elements":["Dolex Forte Acetaminophen, Aspirin, Caffeine POLYETHYLENE GLYCOL 400 TALC STARCH, CORN SILICON DIOXIDE POVIDONE K30 HYPROMELLOSE, UNSPECIFIED CELLULOSE, MICROCRYSTALLINE STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE WATER (Capsule-Shaped Tablet) HH6"],"spl_unclassified_section":["Drug Facts .","Dist. by/ por: Pharmadel LLC New Castle, DE 19720 Questions? +1-866-359-3478 **This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength"],"stop_use":["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 ringing in the ears or loss of hearing occurs redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear. These could be signs of a serious condition."],"storage_and_handling":["Other information store between 68-77˚F (20-25˚C) keep box for important information read all product information before use"],"version":"2","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 (NSAID) may cause severe allergic reactions. Symptoms 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 everyday while using this product Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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) have 3 or more alcoholic drinks everyday while using this product take more or for a longer time than directed 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 a rapid heartbeat. Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer 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 you have asthma stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis any other drug, or are 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 ringing in the ears or loss of hearing occurs redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear. These could be signs of a serious condition. If pregnant or breastfeeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of 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 (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."]}