{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) 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 of age and over take 2 caplets every 6 hours: not more than 8 caplets in 24 hours under 12 years ask a doctor"],"dosage_and_administration_table":["
adults and children 12 years of age and over take 2 caplets every 6 hours: not more than 8 caplets in 24 hours
under 12 years ask a doctor
"],"effective_time":"20200314","id":"b46d561d-5cc7-4ede-82c9-681d0ba719af","inactive_ingredient":["Inactive ingredients benzoic acid, carnauba wax, FD&C blue#1, hydroxypropylcelluose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitanmonolaurate, stearic acid, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & 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":{},"package_label_principal_display_panel":["Packaging image description"],"purpose":["Purpose Pain reliever Pain reliever Pain reliever aid"],"questions":["Questions or comments? 1-(973) 276-0740"],"set_id":"4f6fd2d8-0783-4bbf-82f7-ceceaf8fc08f","spl_product_data_elements":["FAIRFIELD HEALTH PRODUCTS EXTRA STRENGTH Acetaminophen, Aspirin, Caffeine ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE BENZOIC ACID CARNAUBA WAX FD&C BLUE NO. 1 HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED LIGHT MINERAL OIL MICROCRYSTALLINE CELLULOSE POLYSORBATE 20 POVIDONE, UNSPECIFIED PROPYLENE GLYCOL DIMETHICONE SORBITAN MONOLAURATE STEARIC ACID TITANIUM DIOXIDE F"],"spl_unclassified_section":["Drug Facts","Has the same Active Ingredient as in Excedrin Extra Strength Distributed by Fairfield Health Products LLC"],"storage_and_handling":["Other information • store at 20°C - 25°C (68° - 77°) • read all product information before using. Keep this box for important information."],"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 behaviour 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 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 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) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Caffeine warnings : 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 • 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 • 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 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 • 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. If pregnant or breast-feeding , ask a health care 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."]}