MedPath

Senna-Lax

1122 - Major

Approved
Approval ID

27a9d749-cc2c-41ba-8679-8f970b972417

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

Major Pharmaceuticals

DUNS: 191427277

Products 2

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

Sennosides

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0904-6522
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sennosides
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (10)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SENNOSIDESActive
Quantity: 8.6 mg in 1 1
Code: 3FYP5M0IJX
Classification: ACTIB
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT

Sennosides

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0904-6725
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sennosides
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (10)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SENNOSIDESActive
Quantity: 8.6 mg in 1 1
Code: 3FYP5M0IJX
Classification: ACTIB
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/10/2020

NDC 0904-6725-80

MAJOR®

Senna Tablets

Natural Vegetable Laxative Ingredient

For Gentle, Predictable Relief of Constipation

Compare to the active ingredient in Senokot® Tablets*

Sennosides 8.6 mg EACH

1000 TABLETS

Major Label

![1122-100BC](/dailymed/image.cfm?name=1122-100BC_10812_IFC+MAJOR+HOSPITAL_Senna- Lax_700532.jpg&id=892565)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/22/2017

Uses

  • relieves occasional constipation (irregularity)
  • generally causes a bowel movement in 6-12 hours

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/22/2017

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/22/2017

Purpose

Laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 12/22/2017

Do not use

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

Do not use

laxative products for longer than one week 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 use of a laxative.

These may indicate a serious condition.

If pregnant or breast-feeding,

ask a health care 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: 12/20/2018

Directions

take preferably at bedtime or as directed by a doctor

age

starting dosage

maximum dosage

Adults and children

12 years of age and older

2 tablets

once a day

4 tablets

twice a day

Children 6 to under

12 years of age

1 tablet

once a day

2 tablets

twice a day

Children 2 to under

6 years of age

1/2 tablet

once a day

1 tablet

twice a day

Children under

2 years of age

ask a doctor

ask a doctor

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 12/20/2018

Other information

  • Each tablet contains:Calcium 25 mg
  • Store at room temperature

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/20/2018

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol and talc

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 12/22/2017

Questions or comments?

(800) 616-2471

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 12/22/2017

Tamper Evident:

Do not use if sealed blister units are broken or damaged.

Product color may slightly vary

due to natural changes of ingredients.

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

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Senna-Lax - FDA Drug Approval Details