{ "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": 3 } }, "results": [ { "spl_product_data_elements": [ "Childrens Mylicon All in One Tummy Relief for Kids Antacid and Antigas BENZYL ALCOHOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED D&C RED NO. 28 GLYCERIN MICROCRYSTALLINE CELLULOSE WATER SODIUM CARBONATE SORBITOL SUCRALOSE XANTHAN GUM CALCIUM CARBONATE CALCIUM CATION CARBONATE ION DIMETHICONE DIMETHICONE" ], "spl_unclassified_section": [ "Drug Facts", "Other information each 5 mL dose contains: calcium 160 mg, sodium 3 mg store between 20-25°C (68-77°F) do not freeze" ], "active_ingredient": [ "Active ingredients (in each 5 mL dose) Calcium carbonate 400 mg Simethicone 40 mg" ], "purpose": [ "Purpose Antacid Antigas" ], "indications_and_usage": [ "Uses relieves: acid indigestion heartburn sour stomach upset stomach associated with these symptoms pressure and bloating commonly referred to as gas overindulgence in food and drink" ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if your child is presently taking a prescription drug. Antacids may interact with certain prescription drugs. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is presently taking a prescription drug. Antacids may interact with certain prescription drugs." ], "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 at 1-800-222-1222" ], "dosage_and_administration": [ "Directions shake well before use measure with dosing cup provided follow directions based on age/weight below or as directed by a doctor repeat as needed do not use the maximum dosage for more than two weeks except under the advice and supervision of a doctor clean dosing cup after use mL = milliliter Age Weight Dosage (mL) under 2 yrs under 24 lbs ask a doctor 2-5 yrs 24-47 lbs 5 mL. Not more than 15 mL in 24 hours. 6-11 yrs 48-95 lbs 10 mL. Not more than 30 mL in 24 hours." ], "dosage_and_administration_table": [ "
AgeWeightDosage (mL)
under 2 yrsunder 24 lbsask a doctor
2-5 yrs24-47 lbs5 mL. Not more than 15 mL in 24 hours.
6-11 yrs48-95 lbs10 mL. Not more than 30 mL in 24 hours.
" ], "inactive_ingredient": [ "Inactive ingredients benzyl alcohol, carboxymethylcellulose sodium, D&C red 28, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum" ], "questions": [ "Questions or comments? call 1-855-848-3284 (English & Spanish)" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel FROM THE MAKERS OF THE #1 PEDIATRICIAN RECOMMENDED INFANT GAS BRAND new! Children’s MYLICON ® Antacid/Antigas All-in-One Tummy Relief for Kids Multi-symptom relief of upset tummies due to bloating, gas, and discomfort from acid indigestion and overeating. Bubble Gum Flavor 4 FL OZ (120 mL) 24 Doses Ages 2-11 Important: Keep this carton for future reference on full labeling TAMPER EVIDENT: do not use if printed safety seal under cap is broken or missing New great-tasting Children’s Mylicon All-in-One Tummy Relief liquid works on contact to quickly soothe upset tummies due to bloating, gas, and discomfort from acid indigestion and overeating. Children’s Mylicon All-in-One Tummy Relief is a multi-purpose solution to help treat more causes of tummy aches and discomfort.. Children’s Mylicon combines the antigas medicine pediatricians recommend most with a soothing antacid for more complete, all-in-one relief for kids ages 2-11. Gluten Free No Saccharin No Botanicals Please visit us @ mylicon.com Manufactured for: Infirst Healthcare Inc., Westport, CT 06880 ©2021 Infirst Healthcare Inc. Children’s MYLICON ® Antacid/Antigas All-in-One Tummy Relief for Kids Multi-symptom relief of upset tummies due to bloating, gas, and discomfort from acid indigestion and overeating. Bubble Gum Flavor Ages 2-11 4 FL OZ (120 mL) New great-tasting Children’s Mylicon All-in-One Tummy Relief liquid works on contact to quickly soothe upset tummies due to bloating, gas, and discomfort from acid indigestion and overeating. Children’s Mylicon combines the antigas medicine pediatricians recommend most with a soothing antacid for more complete, all-in-one relief for kids ages 2-11. Gluten Free No Saccharin or Botanicals SEE CARTON FOR FULL LABELING Please visit us @ mylicon.com Manufactured for: Infirst Healthcare Inc. Westport, CT 06880 ©2021 Infirst Healthcare Inc. Mylicon 4 oz Carton Mylicon 4 oz label" ], "set_id": "0952eba8-6de2-4a77-956d-339fab437472", "id": "0bb08753-8604-dcd1-e063-6294a90a4bd1", "effective_time": "20240101", "version": "2", "openfda": { "application_number": [ "M002" ], "brand_name": [ "Childrens Mylicon All in One Tummy Relief for Kids" ], "generic_name": [ "ANTACID AND ANTIGAS" ], "manufacturer_name": [ "Infirst Healthcare Inc." ], "product_ndc": [ "62372-410" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CALCIUM CARBONATE", "DIMETHICONE" ], "rxcui": [ "2599608", "2599612" ], "spl_id": [ "0bb08753-8604-dcd1-e063-6294a90a4bd1" ], "spl_set_id": [ "0952eba8-6de2-4a77-956d-339fab437472" ], "package_ndc": [ "62372-410-04" ], "is_original_packager": [ true ], "nui": [ "N0000010282" ], "pharm_class_pe": [ "Skin Barrier Activity [PE]" ], "unii": [ "H0G9379FGK", "92RU3N3Y1O" ] } } ] }