Active Ingredient
(in each 118 mL delivered dose)
Dibasic sodium phosphate 7 g
Monobasic sodium phosphate 19 g
The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Pure And Gentle Laxative (NDC 53329-014). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you, ask a doctor or pharmacist before use if you, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each 118 mL delivered dose)
Dibasic sodium phosphate 7 g
Monobasic sodium phosphate 19 g
Saline laxative
Dosage warning: Using more than one enema in 24 hours can be harmful.
For rectal use only.
are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
These symptoms may indicate a serious condition.
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away: 1-800-222-1222.
(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:
(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:
benzalkonium chloride, disodium EDTA, purified water
866-323-0107
Manufactured for: Medline Industries, Inc.
Three Lakes Drive, Northfield, IL 60093 USA
Made in USA
www.medline.com
1-800-MEDLINE
REF: CUR095005
RC21NPX
* Please review the disclaimer below.