{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 250 mg. Aspirin (NSAID*) 250 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug"],"ask_doctor":["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_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are ■ taking a prescription drug for gout, diabetes, or arthritis ■ taking any other drug, or under a doctor’s care for any serious condition"],"do_not_use":["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"],"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 over) Take 2 caplets every 6 hours as needed; not more than 8 caplets in 24 hours Children under 12 years: Ask a doctor"],"effective_time":"20250908","id":"3e4ce426-b2b3-feae-e063-6294a90a95c7","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":["Medique Pain Off"],"generic_name":["ACETAMINOPHEN, ASPIRIN, CAFFEINE"],"is_original_packager":[true],"manufacturer_name":["Unifirst First Aid Corporation"],"nui":["N0000175739","N0000175729","N0000175790","M0023046","N0000000160","N0000008836","M0001335","N0000175722","N0000175578","N0000008832"],"package_ndc":["47682-238-13","47682-238-33","47682-238-99","47682-238-47"],"pharm_class_cs":["Xanthines [CS]","Anti-Inflammatory Agents, Non-Steroidal [CS]"],"pharm_class_epc":["Central Nervous System Stimulant [EPC]","Methylxanthine [EPC]","Nonsteroidal Anti-inflammatory Drug [EPC]","Platelet Aggregation Inhibitor [EPC]"],"pharm_class_moa":["Cyclooxygenase Inhibitors [MoA]"],"pharm_class_pe":["Central Nervous System Stimulation [PE]","Decreased Prostaglandin Production [PE]","Decreased Platelet Aggregation [PE]"],"product_ndc":["47682-238"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308297"],"spl_id":["3e4ce426-b2b3-feae-e063-6294a90a95c7"],"spl_set_id":["c2d7af6b-f477-2462-e053-2995a90aff0f"],"substance_name":["CAFFEINE","ACETAMINOPHEN","ASPIRIN"],"unii":["3G6A5W338E","362O9ITL9D","R16CO5Y76E"]},"other_safety_information":["Other information ■ read all product information before using. Keep box for important information. ■ store at room temperature 68º-77ºF (20º-25ºC) ■ avoid excessive heat and humidity ■ tamper evident sealed packets ■ do not use any opened or torn packets ■ each caplet contains: Magnesium 0.58 mg"],"package_label_principal_display_panel":["Medique® Pain-Off® Extra Strength Pain Relief Alivio al dolor extra fuerte Pain Reliever/Fever Reducer • Acetaminophen 250 mg Aspirin (NSAID) 250 mg Alivia el Dolor/Reduce la Fiebre • Acetaminofeno 250 mg Aspirina (AINE) 250 mg Pain Reliever Aid • Caffeine 65 mg Ayunda al alivio del dolor • Cafina 65 mg Pull to Open Tire Para Abrir 200 Caplets (100 x 2) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Untarias 228RSP Medique"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery."],"purpose":["Purpose Pain reliever/fever reducer Pain reliever/fever reducer Pain reliever aid"],"questions":["Questions or comments? 1-800-634-7680"],"set_id":"c2d7af6b-f477-2462-e053-2995a90aff0f","spl_product_data_elements":["Medique Pain Off Acetaminophen, Aspirin, Caffeine SILICON DIOXIDE TALC CAFFEINE CAFFEINE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED STARCH, CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN POVIDONE, UNSPECIFIED (white to off white with specks) S53 (capsule shaped, biconvex)"],"spl_unclassified_section":["Drug Facts"],"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 ■ 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 appear These could be signs of a serious condition."],"version":"10","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 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 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"]}