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healthy accents enema

Dosage form: enema
Ingredients: SODIUM PHOSPHATE, DIBASIC 7g in 118mL, SODIUM PHOSPHATE, MONOBASIC 19g in 118mL
Labeler: DZA Brands LLC
NDC Code: 55316-002

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.

DZA Brands, LLC Enema Drug Facts

Active ingredients (in each 118 mL delivered dose)

Dibasic sodium phosphate 7 g

Monobasic sodium phosphate 19 g

Purpose

Saline laxative

Uses
  • relieves occasional constipation

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
  • a sodium-restricted diet
  • abdominal pain, nausea or vomiting
  • kidney disease, heart problems, or are dehydrated
  • noticed a sudden change in bowel habits that lasts over 2 weeks

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

do not use

  • more than directed. Serious side effects may occur from excess dosage.
  • for more than 3 days

Stop use and ask a doctor if
  • you have rectal bleeding
  • you have no bowel movement after use of a laxative

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 & children 12 years and overone bottle once daily
children 2 to under 12 years½ bottle once daily
children under 2 yearsdo not use

Other information
  • each 118 mL contains: sodium 4.3 g
  • store at room temperature 20º-25ºC (68º-77ºF)
  • this product generally produces bowel movement in 1 to 5 minutes

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

1-866-322-2439

Package/Label Principal Display Panel

Compare to Fleet® Enema Saline active ingredients

ready-to-use

enema

saline laxative

for relief of occasional constipation

pre-mixed

latex free

{Insert # of Packaged Bottles} pack

Enema Carton Image 1

Enema Carton Image 2

HEALTHY ACCENTS ENEMA 
saline enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-002
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC (SODIUM) SODIUM PHOSPHATE, DIBASIC7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC (SODIUM) SODIUM PHOSPHATE, MONOBASIC19 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
WATER 
Packaging
#Item CodePackage Description
1NDC:55316-002-362 BOTTLE (BOTTLE) in 1 CARTON
1133 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/07/2010
Labeler - DZA Brands LLC (090322194)

Revised: 01/2012
Document Id: 54477a96-7de1-480a-a2b8-5430617d6a27
Set id: 54477a96-7de1-480a-a2b8-5430617d6a27
Version: 1
Effective Time: 20120126
 
DZA Brands LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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