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 59 mL delivered dose)

Dibasic sodium phosphate 3.5 g............. Saline Laxative

Monobasic sodium phosphate 9.5 g......... Saline Laxative

Uses

for relief of occasional constipation

Warnings

For rectal use only

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


Ask a doctor before using this product if the child
Ask a doctor before using any laxative if the child has

Stop use and ask a doctor if the child has
These symptoms may indicate 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

Single Daily Dosage

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

Do not use if child is taking another sodium phosphates product.

children 5 to 11
one bottle as directed by a doctor
children 2 to under 5 years
one-half bottle (see below)
children under 2 years
DO NOT USE
One-half bottle preparation:Unscrew cap and remove 2 table spoons of liquid with a measuring spoon. Replace cap and follow directions below.

Other information

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

305-382-3288

enemakids

GADAVYT ENEMA 
dibasic sodium phosphate, monobasic sodium phosphate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-105
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC3.5 g  in 59 mL
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC9.5 g  in 59 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:53113-105-6666 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: d273c7e7-0dc8-4921-84d2-cf77f1f777eb
Set id: 924882a6-a8e6-4869-b6a6-a2fd931fe248
Version: 1
Effective Time: 20121031
 
Gadal Laboratories Inc