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NDC 50804-0004-02 GOOD SENSE READY TO USE 7; 19 g/133mL; g/133mL Details
GOOD SENSE READY TO USE 7; 19 g/133mL; g/133mL
GOOD SENSE READY TO USE is a RECTAL ENEMA in the HUMAN OTC DRUG category. It is labeled and distributed by Good Sense. The primary component is SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM.
Product Information
| NDC | 50804-0004 |
|---|---|
| Product ID | 50804-004_501adc64-2a1a-486a-ad44-4afc65903bb8 |
| Associated GPIs | 46109902105100 |
| GCN Sequence Number | 003029 |
| GCN Sequence Number Description | sodium phosphate,mono-dibasic ENEMA 19G-7G/118 RECTAL |
| HIC3 | Q3S |
| HIC3 Description | LAXATIVES, LOCAL/RECTAL |
| GCN | 66559 |
| HICL Sequence Number | 001330 |
| HICL Sequence Number Description | SODIUM PHOSPHATE,MONOBASIC/SODIUM PHOSPHATE,DIBASIC |
| Brand/Generic | Generic |
| Proprietary Name | GOOD SENSE READY TO USE |
| Proprietary Name Suffix | LAXATIVE |
| Non-Proprietary Name | sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | ENEMA |
| Route | RECTAL |
| Active Ingredient Strength | 7; 19 |
| Active Ingredient Units | g/133mL; g/133mL |
| Substance Name | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM |
| Labeler Name | Good Sense |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 50804-0004-02 (50804000402)
| NDC Package Code | 50804-004-02 |
|---|---|
| Billing NDC | 50804000402 |
| Package | 2 BOTTLE, PLASTIC in 1 CARTON (50804-004-02) / 133 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2018-12-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ec949e21-c54c-4b12-898c-6419bfedd23a Details
SPL UNCLASSIFIED SECTION
Use
Warnings
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
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
PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| GOOD SENSE READY TO USE
LAXATIVE
sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema |
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| Labeler - Good Sense (076059836) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Natureplex LLC | 062808196 | MANUFACTURE(50804-004) | |
Revised: 7/2021
Document Id: 501adc64-2a1a-486a-ad44-4afc65903bb8
Set id: ec949e21-c54c-4b12-898c-6419bfedd23a
Version: 2
Effective Time: 20210716