SALINE ENEMA- saline enema enema 
Blossom Pharmaceuticals

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

Purpose

Warnings:

For rectal use only



As a doctor before use if you have:


Indications & Usage

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:

Dosage & Administration

Single daily dose

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.


How to use this enema:

REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING.

Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with the other hand and pull gently to remove.

See image on box

Positioning

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

See image on box

Knee-chest position: Kneel, then lower head and chest forward until the left side of face is resting on surface. Position arms comfortably.

See image on box

Administering Enema

INACTIVE INGREDIENT

Inactive ingredient: Water

Principal Display Panel

saline enema.jpg

saline enema

SALINE ENEMA 
saline enema enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-002
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
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61767-002-011 in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/01/2014
Labeler - Blossom Pharmaceuticals (677381470)
Establishment
NameAddressID/FEIBusiness Operations
Blossom Pharmaceuticals677381470manufacture(61767-002)

Revised: 1/2014
Document Id: 4e78a959-948f-4b34-bd90-21ced9cb128a
Set id: 60d838d9-e9f3-4239-bf18-a29b4e468510
Version: 2
Effective Time: 20140130
 
Blossom Pharmaceuticals