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QUALITY CHOICE SINGLE SALINE LAXATIVE

Medically reviewed on August 18, 2016

Dosage form: enema
Ingredients: SODIUM PHOSPHATE, DIBASIC 7g in 118mL, SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 19g in 118mL
Labeler: CDMA
NDC Code: 63868-380

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.

QUALITY CHOICE SINGLE SALINE ENEMA
LAXATIVE

Drug Facts

Active ingredients (in each 118mL delivered dose)Purpose
Dibasic Sodium Phosphate 7 gSaline laxative
Monobasic Sodium Phosphate 19 gSaline laxative

Use

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
  • already used a laxative for more than 1 week
  • have kidney disease
  • have heart problems
  • are dehydrated
  • are 55 years old or older
  • are on a sodium-restricted diet

Ask a doctor before using any laxative if you have
  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

When using this product
  • do not use more than directed. Serious side effects may occur from excess dosage
  • do not use for more than 3 days

Stop use and ask a doctor if
  • you have bleeding
  • the condtion worsens or does not improve within 7 days
  • you have no bowel movement within 30 minutes of enema use
  • you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)

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: 800-222-1222.

Directions

Single daily dosage (per 24 hours)
Do not use more unless directed by a doctor. See Warnings.

Do not use if taking another sodium phosphate product.

Adults and children 12 years old and older1 bottle once daily
Children 2 to under 12 years old1/2 bottle once daily
Children under 2 yearsDO NOT USE

Other information
  • each 118 ml contains 4.4 g sodium
  • store at 15 to 30°C (59 to 86°F)
  • additional liquids by mouth are recommended while using this product
  • this product generally produces a bowel movement in 1 to 5 minutes
  • carton sealed for safety. Do not use if top or bottom flap of the carton is torn or missing

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

866-323-0107 or www.natureplex.com

Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

NDC# 63868-380-45

QC®
QUALITY
CHOICE

* Compare to the
active ingredients
in FLEET ® Enema

Enema

Relieves Occasional
Constipation

Complete, Ready-to-Use

SODIUM PHOSPHATES
RECTAL SOLUTION

Latex Free

Comfortable,
Lubricated Tip

Works In
Minutes

1
Bottle
4.5 Fl Oz (133 mL)

QUALITY CHOICE SINGLE SALINE   LAXATIVE
sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-380
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC (PHOSPHATE ION and SODIUM CATION) SODIUM PHOSPHATE, DIBASIC7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (PHOSPHATE ION and SODIUM CATION) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM19 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
WATER 
Packaging
#Item CodePackage Description
1NDC:63868-380-451 BOTTLE in 1 CARTON
1133 mL in 1 BOTTLE
2NDC:63868-380-902 BOTTLE in 1 CARTON
2133 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33406/01/2010
Labeler - CDMA (011920774)
Establishment
NameAddressID/FEIOperations
Natureplex LLC062808196MANUFACTURE(63868-380)

 
CDMA

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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