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NDC 61919-0498-60 DOCUSATE SODIUM 50; 8.6 mg/1; mg/1 Details
DOCUSATE SODIUM 50; 8.6 mg/1; mg/1
DOCUSATE SODIUM is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by DIRECTRX. 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: 61919-0498-60Last 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: 61919-0498-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners
Product Information
| NDC | 61919-0498 |
|---|---|
| Product ID | 61919-498_861a97c1-c92a-6139-e053-2991aa0a17f9 |
| Associated GPIs | 46991002770320 |
| 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 | DOCUSATE SODIUM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DOCUSATE SODIUM |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 50; 8.6 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DOCUSATE SODIUM; SENNOSIDES |
| Labeler Name | DIRECTRX |
| 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 61919-0498-60 (61919049860)
| NDC Package Code | 61919-498-60 |
|---|---|
| Billing NDC | 61919049860 |
| Package | 60 TABLET, FILM COATED in 1 BOTTLE (61919-498-60) |
| Marketing Start Date | 2018-11-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 861a97c1-c929-6139-e053-2991aa0a17f9 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Do not use
laxative products for longer than 1 week unless directed by a doctor
if you are 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 continues over a period of 2 weeks
Stop use and ask a doctor if
you have rectal bleeding or fail to have a bowel movement after the use of a laxative. These may indicate a serious condition.
If pregnant or breast feeding,
ask a healthcare professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center immediately.
INSTRUCTIONS FOR USE
take preferably at bedtime or as directed by a doctor
age
starting dosage
maximum dosage
Adults and children 12 years and over
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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions:
Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.
Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day
Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day
Children to2 to under 6 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day
Children under 2 years - Ask a doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| DOCUSATE SODIUM
docusate sodium tablet, film coated |
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| Labeler - DIRECTRX (079254320) |
| Registrant - DIRECTRX (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DIRECTRX | 079254320 | repack(61919-498) | |