{"active_ingredient":["Active Ingredient (in each tablet) Aspirin 325 mg (NSAID) * *nonsteroidal anti-inflammatory drug"],"dosage_and_administration":["Directions DRINK A FULL GLASS OF WATER WITH EACH DOSE adults and children 12 years and over : 1-2 tablets every 4 hours while symptoms last, but not more than 12 tablets in 24 hours. Children under 12 years: ask a doctor"],"effective_time":"20180218","id":"d18746db-ee0c-4e00-b4b1-dfd10e32d1b3","inactive_ingredient":["Inactive Ingredients croscarmellose sodium, D&C Yellow #10 (Al-Lake), FD&C yellow #6 (Al-Lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, PVP, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves headache menstrual pain muscle pain toothache minor pain or arthritis pain and fever of colds"],"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."],"openfda":{"application_number":["part343"],"brand_name":["Aspirin"],"generic_name":["ASPIRIN"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"nui":["N0000000160","N0000008836","M0001335","N0000175722","N0000175578","N0000008832"],"original_packager_product_ndc":["54738-111"],"package_ndc":["71610-034-65"],"pharm_class_cs":["Anti-Inflammatory Agents, Non-Steroidal [CS]"],"pharm_class_epc":["Nonsteroidal Anti-inflammatory Drug [EPC]","Platelet Aggregation Inhibitor [EPC]"],"pharm_class_moa":["Cyclooxygenase Inhibitors [MoA]"],"pharm_class_pe":["Decreased Prostaglandin Production [PE]","Decreased Platelet Aggregation [PE]"],"product_ndc":["71610-034"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198467"],"spl_id":["d18746db-ee0c-4e00-b4b1-dfd10e32d1b3"],"spl_set_id":["49f46b08-b2fe-4e4d-b235-983dab9740cc"],"substance_name":["ASPIRIN"],"unii":["R16CO5Y76E"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 325mg NDC 71610-034 - Aspirin EC (NSAID) 325mg - Rx Only Bottle Label 325mg"],"purpose":["Purpose Pain reliever/ Fever Reducer"],"questions":["Questions or Comments Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742"],"set_id":"49f46b08-b2fe-4e4d-b235-983dab9740cc","spl_product_data_elements":["Aspirin Aspirin CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C YELLOW NO. 6 METHACRYLIC ACID POLYETHYLENE GLYCOL 1000 PROPYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN STEARIC ACID TALC TITANIUM DIOXIDE HYPROMELLOSES ASPIRIN ASPIRIN AP;011"],"spl_unclassified_section":["Other Information avoid excessive heat or humidity store at 15-30 °C (59-86 °F)","Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 325mg 100 71610-034-65 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20180218JH Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["
Count 325mg
100 71610-034-65
"],"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 signs of Reye’s syndrome, a rare but serious illness. Allergy Alert: Aspirin may cause a severe allergic reaction which may include hives asthma (wheezing) shock facial swelling 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 takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others) takes more or for a longer time than directed have 3 or more alcoholic drinks every day while using this product. Do not use if you have ever had an allergic reaction to any other pain reliever / fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, lever 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 taking any other drug under a doctor’s care for any serious condition Stop use and ask a doctor if you experiences 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 redness or swelling is present in the painful area any new symptoms appear ringing in the ears or a loss of hearing occurs 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."]}