{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "Alka-Seltzer Original Flavor Alka-Seltzer Original Flavor ANHYDROUS CITRIC ACID SODIUM BICARBONATE ASPIRIN ASPIRIN Alka;Seltzer" ], "active_ingredient": [ "Active ingredient (in each tablet) Buffered aspirin 325 mg (NSAID)*" ], "purpose": [ "Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug" ], "indications_and_usage": [ "Uses ● temporarily relieves minor aches and pains due to: ● headache ● muscle pain ● backache ● toothache ● menstrual pain ● colds ● minor pain of arthritis ● temporarily reduces fever" ], "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: Aspirin may cause a severe allergic reaction which may include: · hives · facial swelling · asthma (wheezing) · shock 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" ], "do_not_use": [ "Do not use ● if you are allergic to aspirin or any other pain reliever/fever reducer ● if you have ever had an allergic reaction to this product or any of its ingredients" ], "ask_doctor": [ "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, liver cirrhosis, or kidney disease ● you are taking a diuretic ● you have asthma ● you have a sodium-restricted diet" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you ar e taking a prescription drug for ● diabetes ● gout ● arthritis" ], "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 last more than 10 days ● fever gets worse or last more than 3 days ● redness or swelling is present ● new symptoms occur ● ringing in the ears or a loss of hearing occurs" ], "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 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": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "Directions ● fully dissolve 2 tablets in 4 ounces of water before taking adults and children 12 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 8 tablets in 24 hours adults 60 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 4 tablets in 24 hours children under 12 years consult a doctor" ], "dosage_and_administration_table": [ "
adults and children 12 years and over2 tablets every 4 hours, or as directed by a doctordo not exceed 8 tablets in 24 hours
adults 60 years and over2 tablets every 4 hours, or as directed by a doctordo not exceed 4 tablets in 24 hours
children under 12 yearsconsult a doctor
" ], "other_safety_information": [ "Other information ● each tablet contains: sodium 568 mg ● store at room temperature. Avoid excessive heat. ● Alka-Seltzer Original Flavor in water contains principally the analgesic sodium acetylsalicylate" ], "inactive_ingredient": [ "Inactive Ingredients anhydrous citric acid, sodium bicarbonate" ], "questions": [ "Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)" ], "package_label_principal_display_panel": [ "Alka-Seltzer Buffered Aspirin (NSAID) / Pain reliever / fever reducer Fast Relief of: Headache Backache Body Aches Muscle Pain ORIGINAL FLAVOR 24 EFFERVESCENT TABLETS (12 - 2 count pouches) Alka-Seltzer Original Flavor 24ct" ], "set_id": "07478020-5ba0-3b67-e054-00144ff88e88", "id": "452648e2-82a6-84f5-e063-6394a90a6df1", "effective_time": "20251204", "version": "10", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Alka-Seltzer Original Flavor" ], "generic_name": [ "ALKA-SELTZER ORIGINAL FLAVOR" ], "manufacturer_name": [ "Bayer HealthCare LLC." ], "product_ndc": [ "0280-0087" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ASPIRIN" ], "rxcui": [ "2606079" ], "spl_id": [ "452648e2-82a6-84f5-e063-6394a90a6df1" ], "spl_set_id": [ "07478020-5ba0-3b67-e054-00144ff88e88" ], "package_ndc": [ "0280-0087-04", "0280-0087-02", "0280-0087-03", "0280-0087-01", "0280-0087-06" ], "is_original_packager": [ true ], "nui": [ "N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]" ], "unii": [ "R16CO5Y76E" ] } } ] }