SALINE ENEMA- sodium phosphate, dibasic and sodium phosphate, monobasic enema 
Dynarex Corporation

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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Enema, Saline

Active Ingredient

( in each 118 mL delivered dose)

Dibasic sodium phosphate 7g

Monobasic sodium phosphate 19g

Purpose

Saline laxative

Uses:

Warnings:

For rectal use only

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

As a doctor before use if you have:

Ask a doctor or pharmacist before use if you are

Laxatives may affect how other drugs work.

Stop use and ask a doctor if:

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)

Other information:

Directions

Do not use more unless directed by a doctor

See Warnings

Adults and children 12 years and older - 1 bottle

Children 2 to under 12 years - 1/2 bottle

Children under 2 years - Do not use. Consult a physician.

Inactive ingredient

Water

Indications and Usage

When using this product

Use of this product:

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 knees bent and arms at rest. (see diagram on box)

Knee-chest position: ´╗┐Kneel, then lower headand chest forward until left side of face is resting on surface. Position arms comfortably. (see diagram on box)

Administering Enema

Principal Display Panel

Saline enema

Saline enema.jpg

Saline enema

SALINE ENEMA 
sodium phosphate monobasic, sodium phosphate dibasic enema
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67777-402
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC (PHOSPHATE ION) SODIUM PHOSPHATE, DIBASIC7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC (PHOSPHATE ION) SODIUM PHOSPHATE, MONOBASIC19 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-402-011 in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/29/2012
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 1/2014
Document Id: 1b7d3bcf-b2b6-43ff-9422-5bea71d87f3b
Set id: 7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5
Version: 4
Effective Time: 20140130
 
Dynarex Corporation