FDA.reportPublic FDA data

SENNA LAXATIVE

Manufacturer
MCKESSON (SUNMARK) | Geri-Care Pharmaceutical Corp | Geri-Care Pharmaceuticals, Corp
Effective date
2018-04-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:54:34

Label at a glance#

ProductSENNA LAXATIVE
Active ingredientSENNOSIDES
Label structure8 sections

Indications and uses

this product generally produces a bowel movement in 6 to 12 hours relieves occasional constipation (irregularity)

Dosage and administration

do not exceed 8 tablets in 24 hours Age Starting Dose Maximum Dose adults and children 12 years of age and older 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor 4 tablets in the morning and 4 tablets at bedtime children under 12 years ask a doctor

Storage and handling

each tablet contains: calcium 40 mg store at room temperature 15-30C (59-86F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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
  • have noticed a sudden change in bowel habits that lasts over two 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 professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed 8 tablets in 24 hours
AgeStarting DoseMaximum Dose
adults and children 12 years of age and older2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor4 tablets in the morning and 4 tablets at bedtime
children under 12 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 40 mg
  • store at room temperature 15-30C (59-86F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, croscarmellose sodium, dicalcium phosphate, hypromellose*, magnesium silicate*, magnesium stearate, mineral oil*, PEG*, silica*, wax*.
*May contain these ingredients.

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

451451

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70677-0041-12022-12-15C16284748780-19d75b9d1-020a-f424-e053-dadaa90a57cesunmark 451
70677-0041-12020-01-31C16284748780-19d75b9d1-020a-f424-e053-dadaa90a57cesunmark 451

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0041-1EA - Each70677-00411aa13bf1-272d-4df7-af81-396f4859e9b712018-07-03

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-004170677-0041-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
MAGNESIUM SILICATE9B9691B2N9IACT
MAGNESIUM STEARATE70097M6I30IACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
HYPROMELLOSES3NXW29V3WOIACT
SENNOSIDES3FYP5M0IJXACTIB
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML · Source PDF

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
efce50ec-8918-fb40-e053-2a95a90ab50b6d6ee6f8-9674-ff4f-e053-2991aa0acf192022-12-14WarningsExact identifier
spl set id: 6d6ee6f8-9674-ff4f-e053-2991aa0acf19

Reported adverse events (FAERS/openFDA)#

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