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Senna Liquid

Senna Liquid, USP 8.8 mg Sennosides per 5 mL

Approved
Approval ID

35d5f217-b101-3cd8-e063-6394a90adccd

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

Belleview Biosciences

DUNS: 131968803

Products 1

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

Senna Liquid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84447-120
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Senna Liquid
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (10)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26C
Classification: IACT
POTASSIUM CITRATEInactive
Code: EE90ONI6FF
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SENNOSIDESActive
Quantity: 8.8 mg in 5 mL
Code: 3FYP5M0IJX
Classification: ACTIB
CITRIC ACID ACETATEInactive
Code: DSO12WL7AU
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/1/2025

BULK SHIPMENT: For institutional or repackaging use only.

NDC 84447-120-01

Senna Liquid

8.8 mg/5 mL

2000, 000 mL

BULK SHIPMENT

Bulk Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/1/2025

Uses

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/1/2025

If pregnant or breast-feeding,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/1/2025

Keep out of reach of children.

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 5/1/2025

In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/1/2025

Active Ingredient (per 5 mL)

Sennosides 8.8 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/1/2025

Purpose

Laxative

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/1/2025

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that has continued for more than 2 weeks

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/1/2025

Stop use and ask a doctor if

  • you have rectal bleeding or failure to have a bowel movement after use of a laxative. These could be a sign of a serious condition.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/1/2025

Directions

  • shake well before use
  • do not exceed recommended dose

Age

Starting Dose

MMaximum Dose

adults and children

12 years of age and over

10 mL to 15 mL once a day preferably at bedtime;

increase as needed or

as recommended by a doctor

15 mL in the morning and 15 mL at bedtime

children under 12 years of age

ask a doctor

ask a doctor

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/1/2025

Other information

  • store at 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]
  • protect from light and moisture
  • a dark brown, cherry flavored syrup supplied in the following:

NDC 84447-120-01: 200,000 mL Drum

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/1/2025

Inactive ingredients

cherry flavor, citric acid, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/1/2025

Questions or comments?

Call 1-352-549-9917

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/1/2025

Manufactured by:
Belleview Biosciences
Brooksville, FL 34604

Belleview Bioscience Logo

WARNINGS SECTION

LOINC: 34071-1Updated: 5/1/2025

Do not use

• laxative products for longer than 1 week unless directed by a doctor

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Senna Liquid - FDA Drug Approval Details