Search by Drug Name or NDC
NDC 62011-0395-01 Stool Softener 50; 8.6 mg/1; mg/1 Details
Stool Softener 50; 8.6 mg/1; mg/1
Stool Softener is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. 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: 62011-0395-01Last Updated: 12/01/2022
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: 62011-0395-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners
Product Information
| NDC | 62011-0395 |
|---|---|
| Product ID | 62011-0395_abddf78b-66dd-4747-a990-751cff4c20cf |
| Associated GPIs | 46991002770320 |
| GCN Sequence Number | 048044 |
| GCN Sequence Number Description | sennosides/docusate sodium TABLET 8.6MG-50MG ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 13483 |
| HICL Sequence Number | 021772 |
| HICL Sequence Number Description | SENNOSIDES/DOCUSATE SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Stool Softener |
| Proprietary Name Suffix | plus stimulant laxative |
| Non-Proprietary Name | docusate sodium and 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 | Strategic Sourcing Services LLC |
| 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 62011-0395-01 (62011039501)
| NDC Package Code | 62011-0395-1 |
|---|---|
| Billing NDC | 62011039501 |
| Package | 100 TABLET in 1 BOTTLE, PLASTIC (62011-0395-1) |
| Marketing Start Date | 2018-12-31 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.03407 |
| Pricing Unit | EA |
| Effective Date | 2022-11-23 |
| NDC Description | HM STOOL SOFTENER-STIM LAX TAB |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |
Standard Product Labeling (SPL)/Prescribing Information SPL 1d23213f-edf7-46ce-bb32-434c9b773d93 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 older | 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
carnauba wax*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol*, silcon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide
*contains one or more of these ingredients
Principal Display Panel
Compare to the active ingredients in Colace®2-IN-1†
Stool Softener
+ Stimulant Laxative
Docusate sodium 50 mg
Sennosides 8.6 mg
For overnight relief of occasional constipation
Tablets
†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by McKesson
One Post Street,San Francisco, CA 94104
INGREDIENTS AND APPEARANCE
| STOOL SOFTENER
PLUS STIMULANT LAXATIVE
docusate sodium and sennosides tablet |
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
| Labeler - Strategic Sourcing Services LLC (116956644) |