{ "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 buffered aspirin SODIUM BICARBONATE ANHYDROUS CITRIC ACID ASPIRIN ASPIRIN ALKA;SELTZER" ], "spl_unclassified_section": [ "Pouch Header/PDP Do not use if pouch is torn or open. Alka-Seltzer ® Buffered aspirin (NSAID) /Pain reliever/fever reducer ORIGINAL FLAVOR [Bayer logo] Fast Relief 2 EFFERVESCENT TABLETS", "Other 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" ], "active_ingredient": [ "Active ingredient Active ingredient (in each tablet) Buffered aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ], "purpose": [ "Purpose Purpose Pain reliever/fever reducer" ], "indications_and_usage": [ "Uses 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 ​Warnings Reye's syndrome 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 Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning 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 directedStomach bleeding warning: This product contains an NSAID, which 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 a doctor before use 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 a doctor or pharmacist before use Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes gout arthritis Stop use and ask a doctor 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 redness or swelling is present new symptoms occur ringing in the ears or a loss of hearing occurs If pregnant 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." ], "do_not_use": [ "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 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 Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes gout arthritis" ], "stop_use": [ "Stop use and ask a doctor 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 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 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 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 Directions Fully dissolve 2 tablets in 4 ounces of water before taking. Adults and children 12 years and over: take 2 tablets every 4 hours, or as directed by a doctor. Do not exceed 8 tablets in 24 hours. Adults 60 years and over: take 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." ], "inactive_ingredient": [ "Inactive ingredients Inactive ingredients anhydrous citric acid, sodium bicarbonate" ], "questions": [ "Questions? Questions? 1-800-986-0369 Dist. By Bayer Healthcare LLC, Whippany, NJ 07981" ], "package_label_principal_display_panel": [ "Alka-Seltzer® Gravity Sleeve (unit dose) - PDP/Label [Bayer logo] Alka- Seltzer ® Buffered aspirin (NSAID)/ Pain reliever/fever reducer ORIGINAL FLAVOR 15 PACKETS OF 2 EFFERVESCENT TABLETS [UPC] Pouch PDP" ], "set_id": "0c7a60e7-0bde-9aa2-e063-6294a90a3209", "id": "0c7a60e7-0bdf-9aa2-e063-6294a90a3209", "effective_time": "20231214", "version": "1", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Alka-Seltzer" ], "generic_name": [ "BUFFERED ASPIRIN" ], "manufacturer_name": [ "Lil' Drug Store Products, Inc." ], "product_ndc": [ "66715-5206" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ASPIRIN" ], "rxcui": [ "2606079" ], "spl_id": [ "0c7a60e7-0bdf-9aa2-e063-6294a90a3209" ], "spl_set_id": [ "0c7a60e7-0bde-9aa2-e063-6294a90a3209" ], "package_ndc": [ "66715-5206-0" ], "is_original_packager": [ true ], "upc": [ "0366715510600" ], "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" ] } } ] }