GADAVYT ENEMA - dibasic sodium phosphate, monobasic sodium phosphate liquid 
Gadal Laboratories 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 ingredients (in each 118 mL delivered dose)

Dibasic sodium phosphate 7 g............. Saline Laxative

Monobasic sodium phosphate 19 g......... Saline Laxative

Uses

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 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


Stop use and ask a doctor if

These could be signs of a serious condition.

If pregnant or breast-feeding,

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.



adults and children 12 years and over
one bottle once daily
children 2 to under 12 years
1/2 bottle once daily
children under 2 years
do not use

Other information

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

305-382-3288

enemaadults

GADAVYT ENEMA 
dibasic sodium phosphate, monobasic sodium phosphate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-104
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:53113-104-45133 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/01/2012
Labeler - Gadal Laboratories Inc (841305639)

Revised: 10/2012
Document Id: b41d79c8-cdd2-410e-9921-3ca86f040b8f
Set id: 8d47021a-c973-4a25-acc3-98e3001ec8db
Version: 2
Effective Time: 20121031
 
Gadal Laboratories Inc