SALINE ENEMA- sodium phosphate monobasic, sodium phosphate dibasic 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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4719 Enema, Saline NDC 67777-402-01

Active Ingredients

( in each 118 mL delivered dose)

Dibasic Sodium Phosphate 7g

Monobasic Sodium Phosphate 19g

Purpose

Saline Laxative

Uses

• For relief of occasional constipation

• This product generally produces bowel movement in 2 to 15 minutes

Warnings:

For rectal use only

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

Do not use

• Laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

• Longer than 1 week unless directed by a doctor

• This product if you are on a low salt diet unless directed by a doctor

• This product if you have kidney disease unless directed by a doctor

Ask a doctor before use if you have:

Noticed a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if:

  • If you have rectal bleeding or fail to have a bowel movement after use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years old and over - 1 bottle once daily

Children 2 to under 12 years of age - 1/2 bottle once daily, discard unused portion

Children under 2 years - Consult a physician.

Other information:

Inactive ingredients

Benzalkonium Chloride, Disodium EDTA, Purified Water

Questions?

1-888-DYNAREX Monday - Friday 9AM - 5PM EST

Label

4719 IN MASTER4719 Enema Saline Laxative

SALINE ENEMA 
sodium phosphate monobasic, sodium phosphate dibasic enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-402
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 ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-402-0248 in 1 CASE08/29/2012
1NDC:67777-402-011 in 1 BOX
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
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: 11/2022
Document Id: ee9fa245-af1a-f31e-e053-2995a90a0f75
Set id: 7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5
Version: 7
Effective Time: 20221129
 
Dynarex Corporation