MedPath

SENNA

SENNA SYRUP Natural Vegitable Lexative

Approved
Approval ID

8b7cc0d5-029b-43f7-a050-8771e7db4551

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 31, 2025

Manufacturers
FDA

ATLANTIC BIOLOGICALS CORP.

DUNS: 047437707

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

SENNA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code17856-8237
Application NumberM
Product Classification
M
Marketing Category
C200263
G
Generic Name
SENNA
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (6)

METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SENNOSIDES A AND BActive
Quantity: 417.12 mg in 237 mL
Code: 1B5FPI42EN
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/24/2024

PRINCIPAL PANEL

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INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/4/2020

Directions

shake well before use
take preferably at bedtime or as directed by a doctor

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/4/2020

Active Ingredient

Active ingredient (in each 5 ml) purpose
Sennosides 8.8 mg …………………………................Laxative

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/4/2020

Uses

relieves occasional constipation (irregularity)
generally causes bowel movement in 6 to 12 hours

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/4/2020

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 SECTION

LOINC: 34071-1Updated: 5/4/2020

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/4/2020

Other Information

  • Avoid accessive heat. Store at room temperature 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/4/2020

Inactive Ingredients

Mythylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucrose

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/4/2020

KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center immediately

Questions?

To Report Adverse Drug Event Call 1(877) 225-6999

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE

MIAMI, FL 33179

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