{"active_ingredient":["Active ingredient (in each suppository) Glycerin USP, 1.2 grams"],"ask_doctor":["Ask a doctor before use if the child has Stomach pain, nausea or vomiting A sudden change in bowel habits lasting more than 2 weeks"],"do_not_use":["Do not use for longer than 1 week unless directed by a doctor."],"dosage_and_administration":["Directions Tear off one suppository from the strip If the suppository seems soft, place it in the refrigerator before use or run cold water over it before removing the foil wrapper Gently remove suppository by peeling apart the wrapper (see illustration 1) Rub a water-based lubricant over the tip or dip it in water. It will help you slide it in smoothly Lie on your side and insert 1 suppository, tapered end first, about the length of your finger into the rectum (see illustration 2) Hold the suppository for about 15-20 minutes to allow time for it to melt Children 2 to under 6 years of age ...................... 1 suppository once daily Children under 2 years ............................................ ask a doctor"],"effective_time":"20260106","id":"553c8839-ee7f-4b94-986f-69ddfbf085c5","inactive_ingredient":["Inactive ingredients purified water, sodium stearate."],"indications_and_usage":["Uses For relief of occasional constipation This product usually produces bowel movement in 1/4 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":["M007.54"],"brand_name":["Proctozone-G"],"generic_name":["GLYCERIN"],"is_original_packager":[true],"manufacturer_name":["Rising Pharma Holdings, Inc."],"nui":["N0000185370","N0000175629","N0000184306","N0000185001","M0000728","M0009417"],"package_ndc":["57237-338-16","57237-338-21","57237-338-51","57237-338-52"],"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":["57237-338"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["421299"],"spl_id":["553c8839-ee7f-4b94-986f-69ddfbf085c5"],"spl_set_id":["8a5c8ad5-3619-4971-967d-165270a20bc8"],"substance_name":["GLYCERIN"],"unii":["PDC6A3C0OX"]},"package_label_principal_display_panel":["NDC 57237-338-21 (2 blisters of 6 suppositories) Proctozone-G TM GLYCERIN SUPPOSITORIES 1.2 g RECTAL LAXATIVE Front Foil (57237-338-16) Back Foil (57237-338-16) NDC 57237-338-52 (5 blisters of 5 suppositories) Front Foli (57237-338-51) Back Foil (57237-338-51) proctozone-G 1.2g 57237-338-21 fig-1 proctozone-G 1.2g 57237-338-21 fig-2 12005007 proctozone g 1.2 g front foil 12005006 proctozone g 1.2 g back foil 13011263 proctozone g 1.2 g carton-22 13011264 proctozone g 1.2 carton-1 12005008 proctozone g front foil 12005012 proctozone g 1.2 g back foil"],"purpose":["Purpose Laxative"],"questions":["Questions or Comments: call 1-844-474-7464"],"set_id":"8a5c8ad5-3619-4971-967d-165270a20bc8","spl_product_data_elements":["Proctozone-G Glycerin WATER SODIUM STEARATE GLYCERIN GLYCERIN clear"],"spl_unclassified_section":["Drug Facts","TAMPER EVIDENT, INDIVIDUALLY SEALED FOR YOUR PROTECTION","Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India Code No.: MH/DRUGS/25-KD/724 Issued: 05/2025"],"stop_use":["Stop use and ask a doctor if you have Rectal bleeding No bowel movement after using this product These may indicate a serious condition."],"storage_and_handling":["Other Information Keep away from excessive heat."],"version":"2","warnings":["Warnings For rectal use only Do not use for longer than 1 week unless directed by a doctor. Ask a doctor before use if the child has Stomach pain, nausea or vomiting A sudden change in bowel habits lasting more than 2 weeks When using this product your child may have rectal discomfort or a burning sensation Stop use and ask a doctor if you have Rectal bleeding No bowel movement after using this product These may indicate a serious condition. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product your child may have rectal discomfort or a burning sensation"]}