OTC Medication Information: GOOD SENSE READY TO USE LAXATIVE

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.

Drug Facts

Active ingredients (in each 118mL delivered dose) Purpose
Dibasic Sodium Phosphate 7 g Saline laxative
Monobasic Sodium Phosphate 19 g Saline laxative

Use

  • relieves occasional constipation
  • this product generally produces bowel movement in 1 to 5 minutes

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 older 1 bottle once daily
Children 2 to under 12 years of age Use Pediatric Enema
Children under 2 years of age DO NOT USE

Other information

  • each 118 ml contains sodium 4.3 g
  • store at 15 to 30°C (59 to 86°F)
  • additional liquids by mouth are recommended while using this product
  • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

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

  • For Relief Of
    Occasional
    Constipation
  • Pre-Mixed
  • Soft, Flexible
    Pre-Lubricated
    Tip

Compare to active ingredients of
Fleet® Enema Saline*

ONE UNIT 4.5 FL. OZ.
(133mL)

Principal Display Panel -- 133 mL Bottle Carton
(click image for full-size original)
GOOD SENSE READY TO USE LAXATIVE
sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-004
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (PHOSPHATE ION and SODIUM CATION) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 7 g in 133 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (PHOSPHATE ION and SODIUM CATION) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 19 g in 133 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
EDETATE DISODIUM
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50804-004-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 133 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (50804-004-01)
2 NDC:50804-004-02 2 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 133 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (50804-004-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 12/04/2018
Labeler — Good Sense (076059836)
Establishment
Name Address ID/FEI Operations
Natureplex LLC 062808196 MANUFACTURE (50804-004)

Revised: 07/2021 Good Sense

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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