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NATUREPLEX by Natureplex, LLC

Dosage form: enema
Ingredients: SODIUM PHOSPHATE, MONOBASIC 19g in 133mL, SODIUM PHOSPHATE, DIBASIC 7g in 133mL
Labeler: Natureplex, LLC
NDC Code: 67234-020

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.

SALINE ENEMA LABEL

Active ingredients (in each 118 mL delivered dose)
Dibasic sodium phosphate 7 g
Monobasic sodium phosphate 19 g

Purpose
Saline Laxative

Uses
  • for relief of occasional constipation

Warnings
For rectal use only
Dosage warning: Using more than one enema in 24 hours can be harmful.

Ask a doctor before using this product if you
  • are on a sodium-restricted diet
  • have kidney disease
  • are 65 or older and under a doctor's care for any medical condition

Ask a doctor before using this 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

Stop use and ask a doctor if you have
  • rectal bleeding
  • no bowel movement within 30 minutes of enema use
  • symptoms of dehydration [feeling thirsty* 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.


Directions
Do not use more unless directed by a doctor. See Warnings.
Do not use if taking another sodium phosphates product.

adults and children 12 years and over
one bottle once daily
children 2 to under 12 years
1/2 bottle once daily
children under 2 years
do not use


Other information

  • each 118 mL contains: sodium 4.4 g
  • additional liquids by mouth are recommended while taking this product
  • this product generally produces a bowel movement within 1-5 minutes
  • store between 15 and 30 C (59 and 86 F)
  • carton sealed for safety. Do not use if top or bottom flap is torn or missing.
  • consult PHYSICIANS' DESK REFERENCE for complete professional labeling.



Inactive ingredients
benzalkonium chloride, disodium EDTA, water

Questions or comments?
1-866-323-0107 or
www.natureplex.com

Package/Label Principle Display Panel
Latex Free
Ready-To-Use
Enema
Saline Laxative
For Occasional Relief of Occasional Constipation
Soft, Easy To Use Bottle
Compare to Fleet


NATUREPLEX  ENEMA
(saline) enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-020
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, MONOBASIC (SODIUM) SODIUM PHOSPHATE, MONOBASIC19 g  in 133 mL
SODIUM PHOSPHATE, DIBASIC (SODIUM) SODIUM PHOSPHATE, DIBASIC7 g  in 133 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
WATER 
Packaging
#Item CodePackage Description
1NDC:67234-020-011 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 CARTON
1133 mL in 1 BOTTLE, WITH APPLICATOR
2NDC:67234-020-022 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 CARTON
2133 mL in 1 BOTTLE, WITH APPLICATOR
3NDC:67234-020-033 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 CARTON
3133 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/01/2010
Labeler - Natureplex, LLC (062808196)
Establishment
NameAddressID/FEIOperations
Natureplex, LLC062808196manufacture

Revised: 02/2012
 
Natureplex, LLC

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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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