{"active_ingredient":["Active ingredient (per suppository) Glycerin, USP 1g"],"ask_doctor":["Ask a doctor before use if your child has: abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks. Stop use and ask a doctor: if your child has rectal bleeding or fails to have a bowel movement after using a laxative. This may indicate a serious condition."],"do_not_use":["Do not use laxative products for longer than 1 week unless directed by a doctor"],"dosage_and_administration":["Directions Children 2 to under 6 years of age: Carefully insert one suppository well into child's 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 2 years old: Consult a doctor."],"effective_time":"20241101","id":"4c627848-1463-4afc-bfd6-e310b1ef0ffa","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 Glycerin Laxative Pediatric"],"generic_name":["GLYCERIN"],"is_original_packager":[true],"manufacturer_name":["Stratus Pharmaceuticals"],"nui":["N0000185370","N0000175629","N0000184306","N0000185001","M0000728","M0009417"],"package_ndc":["58980-409-12","58980-409-25"],"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":["58980-409"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["252062"],"spl_id":["4c627848-1463-4afc-bfd6-e310b1ef0ffa"],"spl_set_id":["6ae6d3c4-bb3b-4436-b76d-8654bf871e66"],"substance_name":["GLYCERIN"],"unii":["PDC6A3C0OX"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 25 Suppository Jar Label NDC 58980-409-25 STRATUSCARE INFANTS & CHILDREN pediatrics Glycerin Suppositories Laxative Distributed by: STRATUS PHARMACEUTICALS INC 25 SUPPOSITORIES DO NOT USE IF INNER SEAL IS BROKEN OR MISSING. Principal Display Panel - 25 Suppository Jar Label"],"purpose":["Purpose Laxative"],"questions":["Questions or comments? 1-800-442-7882"],"set_id":"6ae6d3c4-bb3b-4436-b76d-8654bf871e66","spl_product_data_elements":["Stratuscare Glycerin Laxative Pediatric 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 your child has rectal bleeding or fails 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)"],"version":"4","warnings":["Warnings For rectal use only. May cause rectal discomfort or burning sensation. Ask a doctor before use if your child has: abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks. Stop use and ask a doctor: if your child has rectal bleeding or fails 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 Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212)."]}