FDA.reportPublic FDA data

Natural Vegetable Laxative with Stool Softener

Manufacturer
Medline Industries, LP
Effective date
2021-10-06
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:34:03

Label at a glance#

ProductNatural Vegetable Laxative with Stool Softener
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure14 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces 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 or older 2 tablets once a day 4 tablets twice a day  children 6 to under 12 years 1 tablet once a day 2 tablets twice a day  children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day  children under 2 years  ask a doctor  ask a doctor

Label contents#

Full prescribing information#

Active ingredients (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 6-12 hours

Do not use

OTC - DO NOT USE SECTION

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 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 lasts over 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 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take preferably at bedtime or as directed by a doctor
  age   starting dosage   maximum dosage
 adults and children 12 years of age or older2 tablets
once a day 		4 tablets
twice a day
 children 6 to under 12 years1 tablet
once a day 		2 tablets
twice a day
 children 2 to under 6 years1/2 tablet
once a day 		1 tablet
twice a day
 children under 2 years ask a doctor ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: c alcium 20 mg
  • each tablet contains: sodium 6 mg  VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax*, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, silicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-MEDLINE (633-5463) Monday-Friday 9AM-5PM CST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

**Compare to the active ingredients in Senokot-S®

NATURAL VEGETABLE LAXATIVE

WITH STOOL SOFTENER

Gentle, Overnight Relief of Constipation

Docusate Sodium, 50 mg

Sennosides, 8.6 mg

TABLETS

Distributed by: Medline Industries, Inc.

Mundelein, IL 60060 www.medline.com 1-800-Medline

**This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OTC49060OTC49060

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-67953329-679-62

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL532B59J990IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ALUMINUM OXIDELMI26O6933IACT
SENNOSIDES3FYP5M0IJXACTIB
DOCUSATE SODIUMF05Q2T2JA0ACTIB

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
d0fea4c6-0769-76ea-e053-2a95a90a04ba9a291893-679b-d8c8-e053-2a95a90ababb2021-11-17WarningsExact identifier
spl set id: 9a291893-679b-d8c8-e053-2a95a90ababb

Reported adverse events (FAERS/openFDA)#

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