{"active_ingredient":["Active ingredients (in each geltab) Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg"],"ask_doctor":["Ask a doctor before use if • you have liver disease • 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 • you have asthma"],"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 use more than directed (see overdose warning) • drink a full glass of water with each dose • adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8 geltabs in 24 hours • children under 12 years: ask a doctor"],"effective_time":"20260427","id":"50037ba9-82af-ab8a-e063-6394a90a0a17","inactive_ingredient":["Inactive ingredients corn starch, D&C yellow #10 aluminum lake, edible black ink, ethyl cellulose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, microcrystalline cellulose, pregelatinized potato starch, purified water, pvpk-30, sorbitol sorbitan solution, stearic acid, talc, titanium dioxide, triacetin."],"indications_and_usage":["Uses Temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: 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 children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M013"],"brand_name":["Acetaminophen , Aspirin and Caffeine"],"generic_name":["ACETAMINOPHEN , ASPIRIN AND CAFFEINE"],"is_original_packager":[true],"manufacturer_name":["Softgel Healthcare Pvt Ltd"],"nui":["N0000000160","N0000008836","M0001335","N0000175722","N0000175578","N0000008832","N0000175739","N0000175729","N0000175790","M0023046"],"package_ndc":["35916-0709-1"],"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":["35916-0709"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["50037ba9-82af-ab8a-e063-6394a90a0a17"],"spl_set_id":["4543e156-1deb-666e-e063-6394a90a719c"],"substance_name":["ASPIRIN","ACETAMINOPHEN","CAFFEINE"],"unii":["R16CO5Y76E","362O9ITL9D","3G6A5W338E"]},"other_safety_information":["Other information • store at room temperature between 20-25°C(68-77°F) • avoid excessive heat, cold and humidity"],"package_label_principal_display_panel":["label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , 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":["Purposes Pain reliever Pain reliever Pain reliever aid"],"set_id":"4543e156-1deb-666e-e063-6394a90a719c","spl_product_data_elements":["Acetaminophen , Aspirin and Caffeine Acetaminophen , Aspirin and Caffeine PROPYLENE GLYCOL SODIUM LAURYL SULFATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE SHELLAC D&C YELLOW NO. 10 ALUMINUM LAKE POVIDONE K30 STARCH, CORN WATER STEARIC ACID FD&C RED NO. 40 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE ETHYLCELLULOSE, UNSPECIFIED STARCH, POTATO GLYCERIN LACTOSE MONOHYDRATE HYPROMELLOSE, UNSPECIFIED LIGHT MINERAL OIL TALC TRIACETIN ISOPROPYL ALCOHOL GELATIN, UNSPECIFIED ASPIRIN ASPIRIN MICROCRYSTALLINE CELLULOSE SORBITOL ACETAMINOPHEN ACETAMINOPHEN CAFFEINE CAFFEINE SORBITAN Dark green - white"],"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 • 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 • any new symptoms occur These could be signs of a serious condition."],"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 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 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 geltabs 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) • have 3 or more alcoholic drinks every day 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 occasional rapid heartbeat."]}