{"active_ingredient":["Active ingredient (per suppository) Glycerin, USP 2 g"],"ask_doctor":["Ask a doctor before use if you have: abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks."],"do_not_use":["Do not use laxative products for longer than 1 week unless directed by a doctor"],"dosage_and_administration":["Directions Adults and children 6 years and over: Carefully insert one suppository well into rectum It need not melt completely to produce laxative action Generally produces bowel movement in 15 minutes to 1 hour Do not exceed one suppository daily unless directed by a doctor Children under 6 years old: do not use"],"effective_time":"20241104","id":"14962a4b-8181-4cb7-ab2b-79877d26860a","inactive_ingredient":["Inactive ingredients purified water, sodium stearate"],"indications_and_usage":["Use For relief of occasional constipation (irregularity) generally produces bowel movement in ¼ to 1 hour."],"keep_out_of_reach_of_children":["Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212)."],"openfda":{"application_number":["M007"],"brand_name":["Stratuscare Adult Glycerin"],"generic_name":["GLYCERIN"],"is_original_packager":[true],"manufacturer_name":["Stratus Pharmaceuticals"],"nui":["N0000185370","N0000175629","N0000184306","N0000185001","M0000728","M0009417"],"package_ndc":["58980-410-12","58980-410-25","58980-410-50"],"pharm_class_cs":["Allergens [CS]","Glycerol [CS]"],"pharm_class_epc":["Non-Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]","Increased IgG Production [PE]"],"product_ndc":["58980-410"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["104155"],"spl_id":["14962a4b-8181-4cb7-ab2b-79877d26860a"],"spl_set_id":["3e1935da-5c1f-4942-98dd-320fade82321"],"substance_name":["GLYCERIN"],"unii":["PDC6A3C0OX"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 50 Suppository Jar Label NDC 58980-410-50 STRATUSCARE ADULT Glycerin Suppositories Laxative Distributed by: STRATUS PHARMACEUTICALS INC DO NOT USE IF INNER SEAL IS BROKEN OR MISSING. 50 SUPPOSITORIES Principal Display Panel - 50 Suppository Jar Label"],"pregnancy_or_breast_feeding":["I f pregnant or breastfeeding , ask a doctor before use."],"purpose":["Purpose Laxative"],"questions":["Questions or comments? 1-800-442-7882"],"set_id":"3e1935da-5c1f-4942-98dd-320fade82321","spl_product_data_elements":["Stratuscare Adult Glycerin Glycerin Glycerin Glycerin Water SODIUM STEARATE"],"spl_unclassified_section":["Drug Facts","Distributed by: Stratus Pharmaceuticals Inc 12379 SW 130th Street Miami, Florida 33186"],"stop_use":["Stop use and ask a doctor: if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition."],"storage_and_handling":["Other information Store glycerin suppositories at room temperature, between 15°C and 30°C (between 59°F and 86°F) Keep container tightly closed"],"version":"4","warnings":["Warnings For rectal use only. May cause rectal discomfort or burning sensation. Ask a doctor before use if you have: abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks. Stop use and ask a doctor: if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition. Do not use laxative products for longer than 1 week unless directed by a doctor I f pregnant or breastfeeding , ask a doctor before use. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212)."]}