GOOD SENSE READY TO USE  LAXATIVE- sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema 
Good Sense

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.

----------

GOOD SENSE® READY TO USE 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

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 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
  • are on a sodium-restricted diet
  • 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

Distributed by:
Perrigo Direct, Inc.
Peachtree City, GA 30269

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

NDC 50804-004-01

GOODSENSE®

Latex Free

Ready To Use
Enema

Saline
Laxative

Compare to active ingredients of
Fleet® Enema Saline*

ONE UNIT 4.5 FL. OZ.
(133mL)

Principal Display Panel - 133 mL Bottle Carton
GOOD SENSE READY TO USE   LAXATIVE
sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-004
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 FORM7 g  in 133 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM19 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:50804-004-011 in 1 CARTON12/04/2018
1133 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:50804-004-022 in 1 CARTON12/04/2018
2133 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/04/2018
Labeler - Good Sense (076059836)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(50804-004)

Revised: 7/2021
Document Id: 501adc64-2a1a-486a-ad44-4afc65903bb8
Set id: ec949e21-c54c-4b12-898c-6419bfedd23a
Version: 2
Effective Time: 20210716
 
Good Sense