{"active_ingredient":["Active ingredient (in each 118 mL delivered dose) Dibasic sodium phosphate 7 g Monobasic sodium phosphate 19 g"],"ask_doctor":["Ask a doctor before use if you have already used a laxative for more than 3 days have kidney disease, have heart problems, or are dehydrated are 55 years of age or older are on a sodium-restricted diet have abdominal pain, nausea or vomiting have a sudden change in bowel habits lasting more than 2 weeks"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work."],"do_not_use":["Do not use on children under 2 years of age"],"dosage_and_administration":["Directions (or as directed by a doctor) Single daily dosage (per 24 hours) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings. adults & children 12 years and over 1 bottle once daily children 2 to under 12 years Use Pediatric Enema children under 2 years DO NOT USE CAUTION: Remove protective shield from enema tip before inserting. Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove. Positions for using this enema: 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 with left arm folded 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. Doing so helps relax muscles around anus. Do not force enema tip into rectum. Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care. Squeeze bottle until nearly all liquid is gone. It is not necessary to empty unit completely, as it containsmore liquid than needed. Remove tip from rectum and stay in position until urge to evacuate is strong (usually 1 to 5 minutes). If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur. Remove protective shield illustration Left Side position illustration Knee-chest position illustration Directions (or as directed by a doctor) Single daily dosage (per 24 hours) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings Adults and children 12 years old and older 1 bottle once daily Children 2 to under 12 years old Use Pediatric Enema Children under 2 years DO NOT USE CAUTION: Remove protective shield from enema tip before inserting. Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove. Positions for using this enema: Left-side position: Lie on left side with knees bent and arms resting comfortably. Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded 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. Doing so helps relax muscles around anus. Do not force enema tip into rectum. Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care. Squeeze bottle until nearly all liquid is gone. It is not necessary to empty bottle completely, as it contains more liquid than needed. Remove tip from rectum and stay in position until urge to evacuate is strong (usually 1 to 5 minutes). If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur. image 1 image 2 image 3"],"dosage_and_administration_table":["
adults & children12 years and over1 bottle once daily
children 2 to under12 yearsUse Pediatric Enema
children under2 yearsDO NOT USE
","
Adults and children 12 years old and older1 bottle once daily
Children 2 to under 12 years oldUse Pediatric Enema
Children under 2 yearsDO NOT USE
"],"effective_time":"20241126","id":"27d44bbd-bd6d-844e-e063-6394a90a6273","inactive_ingredient":["Inactive ingredients benzalkonium chloride, disodium EDTA, purified water"],"indications_and_usage":["Uses relieves occasional constipation this product generally produces bowel movement in 1 to 5 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 Laxative"],"generic_name":["SODIUM PHOSPHATE"],"is_original_packager":[true],"manufacturer_name":["Medline Industries, LP"],"package_ndc":["53329-014-11","53329-014-58"],"product_ndc":["53329-014"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["283100"],"spl_id":["27d44bbd-bd6d-844e-e063-6394a90a6273"],"spl_set_id":["e3165538-75dd-4f0f-adc8-d4075de10f1e"],"substance_name":["SODIUM PHOSPHATE, DIBASIC","SODIUM PHOSPHATE, MONOBASIC"],"unii":["GR686LBA74","3980JIH2SW"]},"package_label_principal_display_panel":["Package Label Label PDP Label V1 RD22NPX"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use."],"purpose":["Purpose Saline laxative"],"questions":["Questions or comments? 866-323-0107"],"recent_major_changes":["Directions (or as directed by a doctor) Single daily dosage (per 24 hours) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings Adults and children 12 years old and older 1 bottle once daily Children 2 to under 12 years old Use Pediatric Enema Children under 2 years DO NOT USE CAUTION: Remove protective shield from enema tip before inserting. Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove. Positions for using this enema: Left-side position: Lie on left side with knees bent and arms resting comfortably. Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded 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. Doing so helps relax muscles around anus. Do not force enema tip into rectum. Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care. Squeeze bottle until nearly all liquid is gone. It is not necessary to empty bottle completely, as it contains more liquid than needed. Remove tip from rectum and stay in position until urge to evacuate is strong (usually 1 to 5 minutes). If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur. image 1 image 2 image 3"],"recent_major_changes_table":["
Adults and children 12 years old and older1 bottle once daily
Children 2 to under 12 years oldUse Pediatric Enema
Children under 2 yearsDO NOT USE
"],"set_id":"e3165538-75dd-4f0f-adc8-d4075de10f1e","spl_product_data_elements":["Pure and Gentle Laxative sodium phosphate BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER SODIUM PHOSPHATE, DIBASIC PHOSPHATE ION SODIUM PHOSPHATE, MONOBASIC PHOSPHATE ION"],"spl_unclassified_section":["Manufacturing Information Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA www.medline.com 1-800-MEDLINE (633-5463) REF: CUR095005 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 you have symtoms of dehydration (thirstiness, dissiness, vomiting, urinating less oftan than normal) These symptoms may indicate a serious condition."],"storage_and_handling":["Other Information each 118 mL contains sodium 4.3 g store at15-30°C (59-86°F) additional liquids by mouth are recommended while using this product Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING"],"version":"13","warnings":["Warnings Dosage warning: Using more than one enema in 24 hours can be harmful. For rectal use only. Do not use on children under 2 years of age Ask a doctor before use if you have already used a laxative for more than 3 days have kidney disease, have heart problems, or are dehydrated are 55 years of age or older are on a sodium-restricted diet have abdominal pain, nausea or vomiting have a sudden change in bowel habits lasting more than 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. When using this product do not use more than directed. Serious side effects may occur from excess dosage do not use for more than 3 days, without asking a doctor Stop use and ask a doctor if you have rectal bleeding you have no bowel movement within 30 minutes of enema use you have symtoms of dehydration (thirstiness, dissiness, vomiting, urinating less oftan than normal) These symptoms may indicate a serious condition. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 1-800-222-1222."],"when_using":["When using this product do not use more than directed. Serious side effects may occur from excess dosage do not use for more than 3 days, without asking a doctor"]}