CVS PHARMACY- saline laxative enema 
CVS Pharmacy

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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CVS PHARMACY
saline laxative enema

Drug Facts

Active ingredients (in each 59 mL delivered dose)Purpose
Dibasic Sodium Phosphate 3.5gSaline laxative
Monobasic Sodium Phosphate 9.5gSaline laxative

Use

Warnings

For rectal use only.

Dosage warning

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

Ask a doctor or pharmacist before using if the child

  • have already used a laxative for more than 3 days
  • have kidney disease, have heart problems, or are dehydrated
  • are 55 years of age or older
  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits lasting more than 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
  • do not use for more than 3 days, without asking a doctor

Stop use and ask a doctor if the child

  • has rectal bleeding
  • has no bowel movement within 30 minutes of enema use
  • has symptoms of dehydration (thirstiness, dizzyness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

(or as directed by a doctor)

Single daily dosage (per 24 hours)

Do not use if taking another sodium phosphate product.

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

children 2 to 11 years1 bottle once daily
children under 2 yearsask a doctor

Other information

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

866-323-0107 or www.natureplex.com

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 66 mL Bottle Carton

CVS
Health

Compare to the active
ingredients in Fleet®
Pedia-Lax Enema*

NDC 59779-969-40

Children's

Ready-to-Use

Enema

SALINE LAXATIVE

AGES
2-11

2.25 FL OZ (66 mL)

PRINCIPAL DISPLAY PANEL - 66 mL Bottle Carton
CVS PHARMACY 
saline laxative enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-969
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM3.5 g  in 59 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM9.5 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:59779-969-401 in 1 CARTON05/20/2014
159 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 finalpart33405/20/2014
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(59779-969)

Revised: 12/2017
Document Id: bec7129b-42c9-45cb-b2b7-b127415ed91e
Set id: 47ffb719-ad13-4530-b1a0-c419c801913a
Version: 3
Effective Time: 20171221
 
CVS Pharmacy