FDA.reportPublic FDA data

Senna-Lax

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2017-06-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:51:42

Label at a glance#

ProductSenna-Lax
Active ingredientSENNOSIDES A AND B
Label structure12 sections

Indications and uses

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

  • 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, or 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

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • preferable at bedtime or a directed by a doctor
  • adults and children 12 years of age and older: 2 tablets once a day: maximum of 4 tablets once a day
  • children (6-12 years) 1tablet once a day: maximum 2 tablets once a day
  • children (2-6 years) ½ tablet once a day: maximum 1 tablet once a day
  • children under 2 years of age: Ask a doctor

Other information

  • Store at room temperature, USP
  • Each tablet contains: Calcium 20 mg

Inactive ingredient

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil and Polyethylene Gycol

Questions or comments? (800) 616-2471

Tamper Evident:

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

Product color may slightly vary due to natural changes of ingredients

Manufactured by:
Contract Pharmacal Corp.
135 Adams Avenue
Hauppauge, NY 11788 USA
www.cpc.com

Distributed By:

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150

Rev. 10/15

Repackaged By: Preferred Pharmaceuticals Inc.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Senna-Lax

(Standardized Senna Concentrate)

8.6 mg Sennosides

100 Tablets

Senna Lax
Senna Lax

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312935sennosides 8.6 MG Oral TabletPSN2
312935sennosides, USP 8.6 MG Oral TabletSCD2
312935sennosides A and B 8.6 MG Oral TabletSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 39 image-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-6442-12020-01-31C16284748780-19d75b9d0-8bed-f424-e053-dadaa90a57ceSenna-Lax
68788-6442-32020-01-31C16284748780-19d75b9d0-8bed-f424-e053-dadaa90a57ceSenna-Lax
68788-6442-82020-01-31C16284748780-19d75b9d0-8bed-f424-e053-dadaa90a57ceSenna-Lax

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-6442-1Senna-Lax100 in 1 BLISTER PACKTABLET1002
68788-6442-3Senna-Lax30 in 1 BLISTER PACKTABLET302
68788-6442-8Senna-Lax120 in 1 BLISTER PACKTABLET1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6442SENNA-LAX (SENNOSIDES) TABLET [PREFERRED PHARMACEUTICALS INC.]2Legacy NDC, 3 package rows20170623_b2729b43-d4f4-4ae1-98e4-57227dfb81ae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-6442-3EA - Each68788-64420265fd75-d299-4865-bf80-62a3192852ca12024-04-05
0904-6522-61EA - Each0904-6522ad1e2e6b-467f-4adb-98d6-790f7f47217012016-07-19

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
68788-644268788-6442-3, 68788-6442-1, 68788-6442-8
0904-6522

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES A AND B1B5FPI42ENACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM SILICATE9B9691B2N9IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT

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
2efe9976-acb6-4e10-91ca-f676700b7cd6b2729b43-d4f4-4ae1-98e4-57227dfb81ae2017-06-23WarningsExact identifier
spl id: 2efe9976-acb6-4e10-91ca-f676700b7cd6
spl set id: b2729b43-d4f4-4ae1-98e4-57227dfb81ae

Reported adverse events (FAERS/openFDA)#

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