{"active_ingredient":["Active ingredient (in each 15mL Tablespoonful = TBSP) Bismuth Subsalicylate 262 mg"],"dosage_and_administration":["Directions • shake well before use use dose cup or tablespoon (TBSP) adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour as needed do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea"],"effective_time":"20241223","id":"29f32457-23c4-d8a8-e063-6294a90a1e0d","inactive_ingredient":["Inactive ingredients benzoic acid, flavor, magnesium aluminium silicate, methylcellulose, purified water, red 22, red 28, saccharin sodium, salicylic acid, simethicone emulsion, sodium salicylate, sorbic acid, xanthan gum"],"indications_and_usage":["Uses relieves • diarrhea • heartburn • indigestion • nausea • upset stomach"],"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":{},"package_label_principal_display_panel":["Packaging pronto1 Spanish"],"purpose":["Purposes Upset stomach reliever and antidiarrheal"],"questions":["Questions? 1-866-838-7456"],"set_id":"d0053c7f-1448-40f6-a7e7-279d2dff926a","spl_product_data_elements":["FLANADOL PRONTO BISMUTH Bismuth Subsalicylate BENZOIC ACID MAGNESIUM ALUMINUM SILICATE METHYLCELLULOSE (100 CPS) WATER D&C RED NO. 22 D&C RED NO. 28 SACCHARIN SODIUM SALICYLIC ACID DIMETHICONE SODIUM SALICYLATE SORBIC ACID XANTHAN GUM METHYL SALICYLATE BISMUTH SUBSALICYLATE SALICYLIC ACID"],"spl_unclassified_section":["Drug Facts","Regular Strength Manufactured for: Jomex Pharmaceuticals, LLC Fairfax Station, VA 22039 USA Manufactured by: GCP Laboratories, Inc. Gulfport, MS 39501 www.jomexusa.com www.flanadolusa.com"],"storage_and_handling":["Other information • each 15 mL tablespoonful contains: sodium 6 mg • salicylate 130 mg • protect from freezing • low sodium • sugar free • avoid excessive heat (over 104°F or 40°C) • visit www.info-xtra.com for health information • TAMPER EVIDENT: Do not use if imprinted neckband is missing or broken"],"version":"2","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 behaviour 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: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products Do not use if you have • an ulcer • a bleeding problem • bloody or black stool Ask a doctor before use if you have • fever • mucus in the stool Ask a doctor or pharmacist before use if you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis When using this product a temporary, but harmless darkening of the stool and/or tongue may occur Stop use and ask a doctor if • symptoms get worse or last more than 2 days • diarrhea lasts more than 2 days • ringing in the ears or loss of hearing occurs If pregnant or breast feeding, ask a health professional before use."]}