FDA.reportPublic FDA data

Sennosides

Manufacturer
Major Pharmaceuticals
Effective date
2025-08-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:35:02

Label at a glance#

ProductSenna-Lax
Active ingredientSENNOSIDES
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not use

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

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

take preferably at bedtime or as directed by a doctor

agestarting dosagemaximum 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 information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 LabelMajor Label

1122-100BC1122-100BC

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6522-61EA - Each0904-6522ad1e2e6b-467f-4adb-98d6-790f7f47217012016-07-19
0904-6725-59EA - Each0904-67255196451e-0a68-4b6f-a004-5970ab0b586812019-03-12
0904-6725-80EA - Each0904-67258fccbdf5-1b69-46ab-b260-bbcc3ef73f7312019-03-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-65220904-6522-61
0904-67250904-6725-80, 0904-6725-59

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSES3NXW29V3WOIACT
TALC7SEV7J4R1UIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SENNOSIDES3FYP5M0IJXACTIB
MALTODEXTRIN7CVR7L4A2DIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSES3NXW29V3WOIACT
TALC7SEV7J4R1UIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SENNOSIDES3FYP5M0IJXACTIB
MALTODEXTRIN7CVR7L4A2DIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3c4461ec-cbb0-633a-e063-6394a90a4a9927a9d749-cc2c-41ba-8679-8f970b9724172025-08-13WarningsExact identifier
spl id: 3c4461ec-cbb0-633a-e063-6394a90a4a99
spl set id: 27a9d749-cc2c-41ba-8679-8f970b972417

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.