MedPath

Senna Laxative

Drug Facts

Approved
Approval ID

2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

PD-Rx Pharmaceuticals, Inc.

DUNS: 156893695

Products 1

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

Senna

PRODUCT DETAILS

NDC Product Code43063-838
Application NumberM007
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 21, 2025
Generic NameSenna

INGREDIENTS (7)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SENNOSIDES A AND BActive
Quantity: 8.6 mg in 1 1
Code: 1B5FPI42EN
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/15/2012

43063838 Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/15/2012

Uses

  • relieves occasional constipation (irregularity)

  • this product generally produces a bowel movement in 6 to 12 hours

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/15/2012

Active ingredient (in each tablet)

Sennosides 8.6mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/15/2012

Purpose

Laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 5/15/2012

Warnings

Do not use

for more than one week unless directed by a doctor

Ask a doctor before use if you

  • have abdominal pain, nausea, or vomiting
  • are taking mineral oil
  • noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

  • you have no bowel movement within 12 hours
  • you have rectal bleeding

These could be signs of a serious condition

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/15/2012

Directions

  • do not exceed recommended dose

Age

Starting Dose

Maximum Dose

adults and children 12 years of age and older

2 tablets once a day preferably at bedtime; increase if needed, or as directed by a doctor

4 tablets twice a day, in the morning and at bedtime

children under 12 years

ask a doctor

ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/15/2012

Other information

***Tamper Evident:**Do not use if safety seal is broken or missing from bottle.

  • each tablet contains: calcium 20 mg, potassium 70 mg

  • store at room temperature

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/15/2012

Inactive ingredients:

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/15/2012

Questions?

Adverse drug event call: (866) 562-2756

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 11/20/2018

16 HOW SUPPLIED

Senna Laxative Tablets are available as follows:

8.6 mg: Brown, round, scored tablet, debossed “SB”. Available in bottles of

10 tablets (NDC 43063-838-10)

30 tablets (NDC 43063-838-30)

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