{"active_ingredient":["Active ingredient (in each 120 mL delivered dose) Mineral oil 100% w/v"],"ask_doctor":["Ask a doctor before use if you have already used a laxative for more than 3 days have abdominal pain, nausea or vomiting have a sudden change in bowel habits that persists over a period of 2 weeks"],"do_not_use":["Do not use on children under 13 years of age on pregnant women on persons with difficulty swallowing on bedridden patients if you are presently taking a stool softener laxative or take with meals"],"dosage_and_administration":["Directions (or as directed by a doctor) Rectal enema dosage is 120 mL in a single daily dosage (per 24 hours) adults & children 13 years and over 1 bottle children under 13 years of age DO NOT USE Caution: Remove green protective shield before inserting: hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove Positioning: Left-side position: Lie on left side with knee bent and arms at rest. Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably. Administering enema: With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus. Do not force the enema tip into rectum as this can cause injury. Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed. Remove enema tip from rectum. This product generally produces a bowel movement in 2 to 15 minutes. Do not retain enema solution in body for longer than 15 minutes. Remove protective shield illustration Left Side position illustration Knee-chest position illustration"],"dosage_and_administration_table":["
adults & children13 years and over1 bottle
children under 13 years of ageDO NOT USE
"],"effective_time":"20241126","id":"27d437bf-4b2b-eb33-e063-6394a90a4ef6","inactive_ingredient":["Inactive ingredient none"],"indications_and_usage":["Uses for relief of occasional constipation this product generally produces bowel movement in 2 to 15 minutes"],"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. (1-800-222-1222)"],"openfda":{"application_number":["M007"],"brand_name":["Pure and Gentle"],"generic_name":["MINERAL OIL"],"is_original_packager":[true],"manufacturer_name":["Medline Industries, LP"],"package_ndc":["53329-013-11"],"product_ndc":["53329-013"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["205121"],"spl_id":["27d437bf-4b2b-eb33-e063-6394a90a4ef6"],"spl_set_id":["96d4cad5-0602-4c31-94ed-3117b4fd4a94"],"substance_name":["MINERAL OIL"],"unii":["T5L8T28FGP"]},"package_label_principal_display_panel":["Package Label label"],"pregnancy_or_breast_feeding":["As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product."],"purpose":["Purpose Lubricant laxative"],"questions":["Questions or comments? 1-866-323-0107 M-F 8 am to 5 pm"],"set_id":"96d4cad5-0602-4c31-94ed-3117b4fd4a94","spl_product_data_elements":["Pure and Gentle mineral oil MINERAL OIL MINERAL OIL"],"spl_unclassified_section":["Manufacturing Information Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 Made in USA www.medline.com 1-800-MEDLINE (633-5463) REF: CUR095010 V1 RD22NPX"],"stop_use":["Stop use and ask a doctor if you have rectal bleeding you have no bowel movement within 30 minutes of enema use"],"storage_and_handling":["Other Information store at room temperature 15-30°C (59-86°F) Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING."],"version":"8","warnings":["Warnings For rectal use only Caution: to be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician. Do not use on children under 13 years of age on pregnant women on persons with difficulty swallowing on bedridden patients if you are presently taking a stool softener laxative or take with meals Ask a doctor before use if you have already used a laxative for more than 3 days have abdominal pain, nausea or vomiting have a sudden change in bowel habits that persists over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding you have no bowel movement within 30 minutes of enema use As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"]}