NATUREPLEX ENEMA- (saline)  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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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

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 you

  • 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

  • you have rectal bleeding
  • 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 (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.

Adults and children 12 years of age and older1 bottle once daily
Children 2 to under 12 years of ageUse Pediatric Enema
Children under 2 years of ageDO 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 - 133 mL Bottle Carton

NDC 67234-020-01

*Compare To Fleet®

Natureplex™

READY TO USE

Enema

Saline

Not Made
with
Natural
Rubber
Latex

For
Relief Of
Occasional
Constipation

Soft,
Easy To
Use
Bottle

1
Bottle
4.5 Fl Oz
(133 mL)

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
NATUREPLEX  ENEMA
(saline) enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-020
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 FORM19 g  in 133 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM7 g  in 133 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:67234-020-011 in 1 CARTON06/01/2010
1133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2NDC:67234-020-022 in 1 CARTON06/01/2010
2133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
3NDC:67234-020-033 in 1 CARTON06/01/2010
3133 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 finalpart33406/01/2010
Labeler - Natureplex, LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex, LLC062808196manufacture(67234-020)

Revised: 5/2018
Document Id: ef59dd61-3db3-4254-bd64-f8d199b7da48
Set id: 0bd6d0a8-33e5-40be-a6c6-33fea92b11dd
Version: 13
Effective Time: 20180524
 
Natureplex, LLC