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NDC 17856-8237-01 SENNA 417.12 mg/237mL Details
SENNA 417.12 mg/237mL
SENNA is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by ATLANTIC BIOLOGICALS CORP.. The primary component is SENNOSIDES A AND B.
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: 17856-8237-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Senna
Product Information
| NDC | 17856-8237 |
|---|---|
| Product ID | 17856-8237_659979e0-fa30-43ee-8920-e64f979838d1 |
| Associated GPIs | 46200060201220 |
| GCN Sequence Number | 002922 |
| GCN Sequence Number Description | sennosides SYRUP 8.8MG/5ML ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 08660 |
| HICL Sequence Number | 001289 |
| HICL Sequence Number Description | SENNOSIDES |
| Brand/Generic | Generic |
| Proprietary Name | SENNA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | SENNA |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 417.12 |
| Active Ingredient Units | mg/237mL |
| Substance Name | SENNOSIDES A AND B |
| Labeler Name | ATLANTIC BIOLOGICALS CORP. |
| 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 17856-8237-01 (17856823701)
| NDC Package Code | 17856-8237-1 |
|---|---|
| Billing NDC | 17856823701 |
| Package | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-8237-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-8237-6) |
| Marketing Start Date | 2020-05-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8b7cc0d5-029b-43f7-a050-8771e7db4551 Details
Active Ingredient
Uses
SPL UNCLASSIFIED SECTION
Age Starting Dose Maximum Dose
adults and children 12 years 2 - 3 teaspoonfuls 3 teaspoonfuls twice a day
and older once a day
6 years to under 12 years of age 1 - 1½ teaspoonfuls once a day 1½ teaspoonfuls twice a day
2 to under 6 years of age ½ - ¾ teaspoon once a day ¾ teaspoon once a day
under 2 years of age consult a doctor consult a doctor
Warnings
Do Not Use • laxative products for longer than 1 week
unless directed by a doctor
Ask a doctor or pharmacist before use if you have
• stomach pain • nausea • vomiting
• notice a sudden change in bowel movement that continues
over a period of 2 weeks
Stop use and ask a doctor if
you have rectal bleeding or failure to have a bowel movement
after use of laxative. These may indicate a serious condition
If pregnant or breast-feeding, ask a health
professional before use
KEEP OUT OF REACH OF CHILDREN SECTION
INGREDIENTS AND APPEARANCE
| SENNA
senna syrup |
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| Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) |
| Registrant - ATLANTIC BIOLOGICALS CORP. (047437707) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| UNIT DOSE SOLUTIONS | 360804194 | repack(17856-8237) | |