{"active_ingredient":["Active ingredient (in each suppository) Bisacodyl USP, 10 mg"],"ask_doctor":["Ask a doctor before use if you have stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks"],"dosage_and_administration":["Directions adults and children 12 years of age and over 1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes children 6 to under 12 years 1/2 suppository in a single daily dose children under 6 years Do not use"],"dosage_and_administration_table":["<table width=\"100%\"><tbody><tr><td><paragraph>adults and children</paragraph><paragraph>12 years of age and over</paragraph></td><td><paragraph>1 suppository in a single daily dose. Peel open plastic. Insert suppository</paragraph><paragraph>well into rectum, pointed end first. Retain about 15 to 20 minutes</paragraph></td></tr><tr><td>children 6 to under 12 years</td><td>1/2 suppository in a single daily dose</td></tr><tr><td>children under 6 years</td><td>Do not use</td></tr></tbody></table>"],"effective_time":"20241022","id":"ad7d1357-40a1-47d3-bb30-77aaf1547659","inactive_ingredient":["Inactive ingredient hard fat"],"indications_and_usage":["Use for relief of occasional constipation (irregularity) this product generally produces bowel movement in 15 minutes to 1 hour"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M007.60"],"brand_name":["Proctozone-B"],"generic_name":["BISACODYL"],"is_original_packager":[true],"manufacturer_name":["Rising Pharma Holdings, Inc."],"nui":["N0000009371","N0000175812","N0000009871"],"package_ndc":["57237-337-04","57237-337-21","57237-337-51","57237-337-03"],"pharm_class_epc":["Stimulant Laxative [EPC]"],"pharm_class_pe":["Increased Large Intestinal Motility [PE]","Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["57237-337"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["198509"],"spl_id":["ad7d1357-40a1-47d3-bb30-77aaf1547659"],"spl_set_id":["c53ed934-3846-4dc8-b97b-c84171c21ae1"],"substance_name":["BISACODYL"],"unii":["10X0709Y6I"]},"other_safety_information":["TAMPER EVIDENT, INDIVIVIDUALLY SEALED FOR YOUR PROTECTION"],"package_label_principal_display_panel":["NDC 57237-337-21 (3 blisters of 4 suppositories) Proctozone-B TM Bisacodyl (USP) 10 mg Suppositories MEDICATED LAXATIVE SUPPOSITORY Gentle, Predictable Relief DO NOT SWALLOW NDC 57237-337-04 (4 suppositories in 1 blister pack) Front Foil NDC 57237-337-04 (4 suppositories in 1 blister pack) Back Foil Proctozone-B-supp-01 Proctozone-B-supp-02 Proctozone-B-supp-03"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask health professional before use."],"purpose":["Purpose Stimulant Laxative"],"questions":["Questions or Comments: Call 1-844-474-7464"],"set_id":"c53ed934-3846-4dc8-b97b-c84171c21ae1","spl_product_data_elements":["Proctozone-B Bisacodyl BISACODYL DEACETYLBISACODYL FAT, HARD"],"spl_unclassified_section":["Drug Facts","Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India CODE NO.: MH/DRUGS/25-KD/724 Issued: 09/2024"],"stop_use":["Stop use and ask a doctor if you need to use a laxative product for longer than one week you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition."],"storage_and_handling":["Other information store at 20-25°C (68-77°F) if suppository softens prior to use, may be placed in refrigerator for short time"],"version":"2","warnings":["Warnings For rectal use only"],"when_using":["When using this product you may experience stomach discomfort, faintness, rectal burning and mild cramps"]}