SALINE LAXATIVE- sodium phosphate enema 
Walgreen Company

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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WALGREENS READY TO USE ENEMA
LAXATIVE

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

Dosage warning

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

For rectal use only.

Do not use

  • on children under 2 years of age

Ask a doctor before use if the child

  • has already used a laxative for more than 3 days
  • has kidney disease, have heart problems, or is dehydrated
  • is on a sodium-restricted diet
  • has abdominal pain, nausea, or vomiting
  • has a sudden change in bowel habits lasting more than 2 weeks

Ask a doctor or pharmacist before use if the child is 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, dizziness, 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 under 12 years of ageUse 1 bottle once daily
children under 2 years of ageDO NOT USE

Other information

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

1-866-323-0107

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 67 mL Bottle Box

Walgreens

Compare to Fleet®
Pedia-Lax® Enema
active ingredients††

NDC 0363-0005-40

READY-TO-USE
Pediatric
Enema
SALINE LAXATIVE

SALINE LAXATIVE
PRE-MIXED

NOT ACTUAL SIZE

2.25 FL OZ (67 mL)

Principal Display Panel - 67 mL Bottle Box
SALINE LAXATIVE 
sodium phosphate enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0005
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM19 g  in 118 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:0363-0005-371 in 1 BOX03/11/2016
1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0363-0005-383 in 1 BOX03/11/2016
2133 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
3NDC:0363-0005-396 in 1 BOX03/11/2016
3133 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
4NDC:0363-0005-111 in 1 BOX08/31/201203/11/2016
4133 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0363-0005-363 in 1 BOX08/31/201203/11/2016
5133 mL in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0363-0005-206 in 1 BOX08/31/201203/11/2016
6133 mL in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0363-0005-4024 in 1 BOX08/31/201203/11/2016
766.5 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 finalpart33408/31/2012
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(0363-0005)

Revised: 3/2021
Document Id: 7c2042b5-460a-4f8d-83f4-ee20a5770f23
Set id: fb260df0-7bda-4299-84a5-44c8f9447798
Version: 9
Effective Time: 20210325
 
Walgreen Company