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NDC 63868-0137-60 Stool Softener plus Laxative 50; 8.6 mg/1; mg/1 Details
Stool Softener plus Laxative 50; 8.6 mg/1; mg/1
Stool Softener plus Laxative is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). 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: 63868-0137-60Last 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: 63868-0137-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners
Product Information
| NDC | 63868-0137 |
|---|---|
| Product ID | 63868-137_5202a0fe-e095-4377-882e-3f61527200f3 |
| 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 plus 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 | QUALITY CHOICE (Chain Drug Marketing Association) |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 63868-0137-60 (63868013760)
| NDC Package Code | 63868-137-60 |
|---|---|
| Billing NDC | 63868013760 |
| Package | 1 BOTTLE in 1 BOX (63868-137-60) / 60 TABLET in 1 BOTTLE |
| Marketing Start Date | 2015-11-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6dbf9db3-7489-458b-ba20-69dd38a0e40c Details
Active Ingredients (in each tablet)
Uses
Warnings
Do not use
- If you are now taking mineral oil, unless directed by a doctor
- laxative products for longer than 1 week 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 continues over a period of 2 weeks.
Directions
- Take preferably at bedtime or as directed by a doctor
|
age | starting dosage | maximum dosage |
| adults and children 12 years of age and older | 2 tablets once a day | 4 tablets twice a day |
| children 6 to under 12 years | 1 tablet once a day | 2 tablets twice a day |
| children 2 to under 6 years | 1/2 tablet once a day | 1 tablet twice a day |
| children under 2 years | ask a doctor | ask a doctor |
Other information
Inactive Ingredients
carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, silicon dioxide, sodium benzoate, stearic acid, talc* and titanium dioxide.
*contains one or more of these ingredients
Principal Display Panel
†Compare to the active ingredients in Senokot-S®
Stool Softener plus laxative
Stool Softener • Laxative
Docusate Sodium, 50 mg/ Sennosides, 8.6 mg
Provides Gentle Relief of: Occasional Constipation
Tablets
†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP ID BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by C.D.M.A., Inc©
43157 W. Nine Mile
Novi, MI 48376-0995
INGREDIENTS AND APPEARANCE
| STOOL SOFTENER PLUS LAXATIVE
docusate sodium, sennosides tablet |
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| Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774) |