FDA.reportPublic FDA data

Senna Plus

Manufacturer
Bryant Ranch Prepack
Effective date
2022-06-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:56:46

Label at a glance#

ProductSenna Plus
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure9 sections

Indications and uses

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

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 7 mg • store at room temperature

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use for more than 1 week unless directed by a doctor

Ask a doctor before use if you -have abdominal  pain, nausea or vomiting -are taking mineral oil -have noticed a sudden change in bowel habits that  lasts over 2 weeks

Stop use and ask a doctor if -you have no bowel movement within 12 hours -you have rectal bleeding. these could signs of 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

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

Other information

STORAGE AND HANDLING SECTION

• each tablet contains: calcium 7 mg

• store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, croscarmellose sodium, dicalcium phosphate, FD and C yellow no. 5 (tartrazine), FD and C yellow no. 6, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, titanium dioxide, triacetin

HOW SUPPLIED

How Supplied Section

NDC: 71335-0977-1: 30 Tablets in a BOTTLE

NDC: 71335-0977-2: 120 Tablets in a BOTTLE

NDC: 71335-0977-3: 60 Tablets in a BOTTLE

NDC: 71335-0977-4: 90 Tablets in a BOTTLE

NDC: 71335-0977-5: 100 Tablets in a BOTTLE

NDC: 71335-0977-6: 28 Tablets in a BOTTLE

NDC: 71335-0977-7: 56 Tablets in a BOTTLE

NDC: 71335-0977-8: 14 Tablets in a BOTTLE

NDC: 71335-0977-9: 20 Tablets in a BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate/ Sennosides 50/8.6 mg Tablet

Label
Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0977-2EA - Each71335-0977b1fb46e0-39b1-4250-8301-d784e2603f8a12019-08-06
71335-0977-3EA - Each71335-0977ab63c285-d6e8-4363-bb39-6846782ffa5f12019-02-13
71335-0977-5EA - Each71335-0977975cbf6d-80da-4b60-968a-c01eb86a27a312019-02-13
57896-455-01EA - Each57896-4550f219bae-0f6b-42bf-b51b-1eabc0b9b74812013-05-02
57896-455-06EA - Each57896-455998bed0f-dc2d-4ae5-8192-7e025d26cbc812015-07-20
57896-455-10EA - Each57896-4559eb9f425-a2c3-4683-bc38-aa178b0407f312018-04-19

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71335-097771335-0977-1, 71335-0977-2, 71335-0977-3, 71335-0977-4, 71335-0977-5, 71335-0977-6, 71335-0977-7, 71335-0977-8, 71335-0977-9
57896-455

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
TALC7SEV7J4R1UIACT
MAGNESIUM STEARATE70097M6I30IACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
SENNOSIDES3FYP5M0IJXACTIB
DOCUSATE SODIUMF05Q2T2JA0ACTIB

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
c7cc5ef1-1808-40b8-893d-0e0a439649a61577c4e5-bc35-48db-b16f-49d6b684d8a22024-01-25WarningsExact identifier
spl set id: 1577c4e5-bc35-48db-b16f-49d6b684d8a2

Reported adverse events (FAERS/openFDA)#

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