PEDIATRIC  SALINE LAXATIVE- sodium phosphate, monobasic, unspecified form and sodium phosphate, dibasic enema 
Natureplex, LLC

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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Pediatric
Saline 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

For rectal use only.

Dosage warning

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

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 are 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 old1 bottle once daily
children under 2 yearsDO NOT USE

Other information

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 67 mL Bottle Carton

Natureplex™

pediatric
ages 2-11

NDC 67234-042-01

ENEMA

*Compare
To
Fleet®

saline laxative

1
Bottle
2.25 Fl Oz
(67 mL)

PRINCIPAL DISPLAY PANEL - 67 mL Bottle Carton
PEDIATRIC   SALINE LAXATIVE
sodium phosphate, monobasic, unspecified form and sodium phosphate, dibasic enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-042
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3.5 g  in 59 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, 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:67234-042-011 in 1 CARTON08/31/2012
167 mL in 1 BOTTLE, WITH APPLICATOR; 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 - Natureplex, LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-042)

Revised: 5/2018
Document Id: c75f4dd4-e4a6-49b4-94df-0979b152fcdb
Set id: 267f80dd-2304-4632-9620-f54fd807da82
Version: 3
Effective Time: 20180524
 
Natureplex, LLC