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NDC 50804-0878-10 Stool Softener Laxative 50; 8.6 mg/1; mg/1 Details
Stool Softener Laxative 50; 8.6 mg/1; mg/1
Stool Softener Laxative is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Good Sense (Geiss, Destin & Dunn, Inc.). The primary component is DOCUSATE SODIUM; SENNOSIDES.
MedlinePlus Drug Summary
Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.
Related Packages: 50804-0878-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Senna
Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.
Related Packages: 50804-0878-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners
Product Information
| NDC | 50804-0878 |
|---|---|
| Product ID | 50804-878_68f4d98d-1def-42cd-a2b5-f30f694e695b |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Stool Softener Laxative |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Docusate sodium, Sennosides |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 50; 8.6 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DOCUSATE SODIUM; SENNOSIDES |
| Labeler Name | Good Sense (Geiss, Destin & Dunn, Inc.) |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 50804-0878-10 (50804087810)
| NDC Package Code | 50804-878-10 |
|---|---|
| Billing NDC | 50804087810 |
| Package | 100 TABLET in 1 BOTTLE, PLASTIC (50804-878-10) |
| Marketing Start Date | 2020-06-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cb40f016-dac5-437f-9418-9ad02d731d06 Details
Uses
Warnings
Do not use
- laxative products for longer than 1 week unless directed by a doctor
- if you are now taking mineral oil, unless directed by a doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over a period of 2 weeks
Directions
- take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
| adults and children 12 years and over | take 2-4 tablets daily |
| children 6 to under 12 years of age | take 1-2 tablets daily |
| children 2 to under 6 years of age | take up to 1 tablet daily |
| children under 2 | ask a doctor |
Other information
Inactive ingredients
Principal Display Panel
Overnight Relief
Stimulant Laxative Plus
Stool Softener
Docusate sodium 50 mg
Sennosides 8.6 mg
*Compare to active ingredients in Colace® 2-IN-1
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.
Distributed by: Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
INGREDIENTS AND APPEARANCE
| STOOL SOFTENER LAXATIVE
docusate sodium, sennosides tablet |
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| Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836) |