{ "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": "2026-08-11", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Alka-Seltzer Kids Tummy ReliefChews calcium carbonate and dimethicone TITANIUM DIOXIDE TRIACETIN SORBITOL MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) WATER WHITE WAX SHELLAC ACACIA CALCIUM CARBONATE CALCIUM CATION CORN SYRUP MALTODEXTRIN METHYLPARABEN CARNAUBA WAX DIMETHICONE DIMETHICONE POTASSIUM HYDROXIDE FD&C RED NO. 40 HYDROGENATED COCONUT OIL PROPYLPARABEN SORBIC ACID HG" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredients and purpoose Active ingredients (in each chewable tablet) Purpose Calcium carbonate 750 mg….................................….…...Antacid Simethicone 80 mg……………………………………….......Antigas" ], "purpose": [ "" ], "indications_and_usage": [ "Uses for the relief of: ● acid indigestion ● heartburn ● sour stomach ● upset stomach associated with these symptoms ● bloating, pressure, or stuffed feeling commonly referred to as gas" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product ● adults and children 12 years and over do not take more than 6 chewable tablets in a 24-hour period ● children 6 to under 12 years do not take more than 4 chewable tablets in a 24-hour period ● if pregnant, do not take more than 6 chewable tablets in 24 hours ● do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician If pregnant or breast-feeding , inform your doctor that you are using this product. Keep out of reach of children." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs." ], "when_using": [ "When using this product ● adults and children 12 years and over do not take more than 6 chewable tablets in a 24-hour period ● children 6 to under 12 years do not take more than 4 chewable tablets in a 24-hour period ● if pregnant, do not take more than 6 chewable tablets in 24 hours ● do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , inform your doctor that you are using this product." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "dosage_and_administration": [ "Directions adults and children 12 years and over • fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor. • do not take more than 6 chewable tablets in a 24-hour period children 6 years to under 12 years • under adult supervision, fully chew then swallow 1 chewable tablet as symptoms occur, or as directed by a doctor. • do not take more than 4 chewable tablets in a 24-hour period children under 6 years consult a doctor if pregnant, do not take more than 6 chewable tablets in 24 hours" ], "dosage_and_administration_table": [ "
adults and children 12 years and over• fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor. • do not take more than 6 chewable tablets in a 24-hour period
children 6 years to under 12 years• under adult supervision, fully chew then swallow 1 chewable tablet as symptoms occur, or as directed by a doctor. • do not take more than 4 chewable tablets in a 24-hour period
children under 6 yearsconsult a doctor
" ], "other_safety_information": [ "Other information ● each chewable tablet contains: calcium 300 mg ● store at room temperature. Avoid excessive heat above 40°C (104°F). ● close cap tightly after use" ], "inactive_ingredient": [ "Inactive ingredients acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C red No.40 aluminum lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, modified starch, potassium hydroxide, pregelatinized modified starch, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, triacetin, water, white wax" ], "questions": [ "Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)" ], "package_label_principal_display_panel": [ "Package label 28 count Works Amazingly Fast! Alka-Seltzer® Kids Tummy ReliefChews® Calcium Carbonate/Antiacid Simethicone/Antigas •6 Symptom Relief• •Upset Stomach •Gas • Bloating •Acid Indigestion •Heartburn •Upset Stomach FRUIT PUNCH 28 CHEWABLE TABLETS AS Tummy Relief Chewables" ], "set_id": "ba48966e-3762-5fdf-e053-2995a90aeb3d", "id": "4525fb4f-fd84-0106-e063-6394a90a6ebd", "effective_time": "20251204", "version": "5", "openfda": { "application_number": [ "M001" ], "brand_name": [ "Alka-Seltzer Kids Tummy ReliefChews" ], "generic_name": [ "CALCIUM CARBONATE AND DIMETHICONE" ], "manufacturer_name": [ "Bayer HealthCare LLC." ], "product_ndc": [ "0280-0051" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CALCIUM CARBONATE", "DIMETHICONE" ], "rxcui": [ "1492387" ], "spl_id": [ "4525fb4f-fd84-0106-e063-6394a90a6ebd" ], "spl_set_id": [ "ba48966e-3762-5fdf-e053-2995a90aeb3d" ], "package_ndc": [ "0280-0051-01" ], "is_original_packager": [ true ], "upc": [ "0016500592815" ], "nui": [ "N0000010282" ], "pharm_class_pe": [ "Skin Barrier Activity [PE]" ], "unii": [ "H0G9379FGK", "92RU3N3Y1O" ] } } ] }