MEDLINE SALINE LAXATIVE FOR CHILDREN- sodium phosphate, dibasic and sodium phosphate, monobasic enema 
Medline Industries, Inc.

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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Drug Facts

Active ingredient

(in each 59 mL delivered dose)

Dibasic sodium phosphate 3.5 g

Monobasic sodium phosphate 9.5 g

Purpose

Saline laxative

Uses

relieves occasional constipation

Warnings

For rectal use only

Dosage warning: Using more than one enema in 24 hours can be harmful.

Ask a doctor before use if you have

a sodium-restricted diet
abdominal pain, nausea or vomiting
kidney disease, heart problems, or are dehydrated
noticed a sudden change in bowel habits that lasts over 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

Stop use and ask a doctor if

you have rectal bleeding
you have no bowel movement after use of a laxative

These may be signs of 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

Do not use more unless directed by a doctor. See Warnings.

Children 2 to 11 years

one bottle once daily

children under

2 years

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.

Remove protective shield illustration

Positioning:

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. Position arms comfortably.

Knee-chest position illustration

Administering enema:

with steady pressure, gently insert enema with tip pointing toward navel.
squeeze bottle until recommended dose is expelled (it is not necessary to empty unit completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing).
remove tip from 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.
maintain 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.

Other Information

each 59 mL contains: sodium 2.2 g
store at room temperature 20-25 deg C (68-77 deg F)
this product generally produces bowel movement in 1 to 5 minutes

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

1-800-633-5463

Side and Principal Display Panel - box

Curad Ready-to-use Enema PDP and drug facts

NDC 53329—015-11

Medline

Pure & Gentle

For Children

Saline

ENEMA

LAXATIVE

Comfortable lubricated tip

 
Easy to Insert
 
Ready-to-Use
 
Latex free
 
Ages 2-11 Years
 
1-2.25 fl oz (66 mL)

Side and Back - box

Curad Ready-to-use Enema side and back of box
MEDLINE SALINE LAXATIVE FOR CHILDREN 
sodium phosphate enema
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53329-015
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC (PHOSPHATE ION) SODIUM PHOSPHATE, DIBASIC3.5 g  in 59 mL
SODIUM PHOSPHATE, MONOBASIC (PHOSPHATE ION) SODIUM PHOSPHATE, MONOBASIC9.5 g  in 59 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-015-111 in 1 BOX
166 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/27/2014
Labeler - Medline Industries, Inc. (025460908)

Revised: 3/2014
Document Id: 8b08e241-00b3-4110-b984-5af6f0c111cf
Set id: 8b08e241-00b3-4110-b984-5af6f0c111cf
Version: 1
Effective Time: 20140327
 
Medline Industries, Inc.