FDA.reportPublic FDA data

Senna Plus

Manufacturer
REMEDYREPACK INC.
Effective date
2019-10-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:00:46

Label at a glance#

ProductSenna Plus
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure8 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Senna Plus

GENERIC: Sennosides and Docusate Sodium

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-1590-0

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: CPC490

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DOCUSATE SODIUM 50mg in 1
  • SENNOSIDES 8.6mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • SODIUM BENZOATE
  • FD&C YELLOW NO. 6
  • SODIUM LAURYL SULFATE
  • FD&C YELLOW NO. 5
  • TITANIUM DIOXIDE
  • STARCH, CORN
  • STEARIC ACID
  • CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
  • CROSCARMELLOSE SODIUM
  • HYPROMELLOSES
  • MAGNESIUM SILICATE
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOLS
  • MINERAL OIL
  • TRIACETIN

Remedy_LabelRemedy_Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-1590-02021-01-29C16284748780-1ba0f9c33-1eec-a910-e053-dadaa90a0b8569b42f8a-6764-402b-a3d0-781a1f2e3b96

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1590SENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [REMEDYREPACK INC.]3Legacy NDC20191010_69b42f8a-6764-402b-a3d0-781a1f2e3b96.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-159070518-1590-0
57896-455

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
MAGNESIUM SILICATE9B9691B2N9IACT
MAGNESIUM STEARATE70097M6I30IACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
HYPROMELLOSES3NXW29V3WOIACT
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
9486ff0d-1964-1184-e053-2995a90a17eb69b42f8a-6764-402b-a3d0-781a1f2e3b962019-10-09WarningsExact identifier
spl id: 9486ff0d-1964-1184-e053-2995a90a17eb
spl set id: 69b42f8a-6764-402b-a3d0-781a1f2e3b96

Reported adverse events (FAERS/openFDA)#

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