PURE AND GENTLE LAXATIVE- sodium phosphate enema 
Medline Industries, LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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014 Pure & Gentle Saline Enema Laxative

Active ingredient

(in each 118 mL delivered dose)

Dibasic sodium phosphate 7 g

Monobasic sodium phosphate 19 g

Purpose

Saline laxative

Uses

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.

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.

Remove protective shield illustration

Positions for using this enema:

Left-side position: lie on left side with knee bent and arms at rest.

Left Side position illustration

Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably.

Knee-chest position illustration

Administering enema:

Other Information

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

866-323-0107

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

Package Label

Label PDP

Label V1 RD22NPX

PURE AND GENTLE LAXATIVE 
sodium phosphate enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-014
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC19 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-014-111 in 1 BOX11/10/2017
1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:53329-014-5824 in 1 CASE11/03/2017
2133 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/09/2014
Labeler - Medline Industries, LP (025460908)

Revised: 9/2022
Document Id: e997512b-6226-3d7b-e053-2995a90aea90
Set id: e3165538-75dd-4f0f-adc8-d4075de10f1e
Version: 12
Effective Time: 20220926
 
Medline Industries, LP