Senna/Docusate Sodium

Manufacturer
Major Pharmaceuticals
Effective date
2012-08-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 01:46:23

Label at a glance#

ProductSenna/Docusate Sodium
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure11 sections

Indications and uses

relieves occasional constipation (irregularity) generally causes bowel movement in 6 to 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 and older   2 tablets once a day   4 tablets twice a day   6 to under 12 years   1 tablet once a day   2 tablets twice a day   children under 6 years   ask a doctor   ask a doctor

Storage and handling

Store at 20º - 25ºC (68º - 77ºF); excursions permitted to 15º - 30ºC (59º - 86ºF).  [See USP Controlled Room Temperature]

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

TAMPER-EVIDENT: Do not use this product if imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing.

Drug Facts

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Standardized Senna Concentrate, Sennosides 8.6 mg

Sodium Dioctylsulfosuccinate 50mg

Purpose

OTC - PURPOSE SECTION

Purposes
 Standardized Senna Concentrate, Sennosides 8.6 mglaxative 
  Sodium Dioctylsulfosuccinate 50 mg  Stool softener

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • nausea
  • vomiting
  • abdominal pain
  • a sudden change in bowel habits that persists over 2 weeks

Stop use and ask a doctor if you have

OTC - STOP USE SECTION

rectal bleeding or failure to have a bowel movement occurs after use of a laxative.  These could be signs of a serious condition.

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overodse, 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
agestarting dosagemaximum dosage
  adults and children 12 years and older  2 tablets once a day  4 tablets twice a day
  6 to under 12 years  1 tablet once a day  2 tablets twice a day
  children under 6 years  ask a doctor  ask a doctor

Other information

STORAGE AND HANDLING SECTION

Store at 20º - 25ºC (68º - 77ºF); excursions permitted to 15º - 30ºC (59º - 86ºF).  [See USP Controlled Room Temperature]

Other Ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Dicalcium Phosphate, FD&C Yellow # 5 Lake**, FD&C Yellow #6 Lake, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Sodium Benzoate, Sodium Lauryl Sulfate, Starch, Stearic Acid, Titanium Dioxide and Triacetin.

**Warning:  Contains FD&C Yellow #5 Lake (Tartrazone) as a color additive.

Questions?

OTC - QUESTIONS SECTION

Adverse Drug Event Call (800) 616-2471

SPL UNCLASSIFIED SECTION

Distributed by

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI  48150 USA

Re-Order No.  301557

PRINCIPAL DISPLAY PANEL SENNA PLUS TABLETS, 8.6/50 MG

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 SENNA PLUS TABLETS 8.6/50 MGSENNA PLUS TABLETS 8.6/50 MG

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5512-52EA - Each0904-551220d61bdf-b11e-4f8b-9db0-7d3b83cbb7d312013-02-11
0904-5512-61EA - Each0904-55124a6495c4-71eb-4dd0-8405-6fc8d09074ab12013-02-13
0904-5512-80EA - Each0904-55125a94eafc-67ec-44d3-9345-15e866beded812013-02-11
0182-1113-01EA - Each0182-11139ca562b5-8cc9-496a-9976-3a2c1fde487212012-07-24
0182-1113-10EA - Each0182-1113f058ef60-b910-4848-b330-e102ef1a780712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA05
SENNOSIDESACTIVE INGREDIENT3FYP5M0IJX5
DOCUSATEACTIVE MOIETYM7P27195AG5
SENNOSIDESACTIVE MOIETY3FYP5M0IJX5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH485
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A85
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO5
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP5
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N95
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I305
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J5
STARCH, TAPIOCAINACTIVE INGREDIENT24SC3U704I5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP5
TARTARIC ACIDINACTIVE INGREDIENTW4888I119H5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP5

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
0904-55120904-5512-61
0182-1113

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 380 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 mgExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPCAPSULE, EXTENDED RELEASE / ORAL51 mgExact identifier — unii candidate
10 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / OPHTHALMIC0.5 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, COATED / ORAL4.8 mgExact identifier — unii candidate
19 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED PELLETS / ORAL4.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO, SUSPENSION / TOPICAL40 %w/vExact identifier — unii candidate
42 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, ORALLY DISINTEGRATING / ORAL184 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
34 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HSOLUTION / ORAL270 mgExact identifier — unii candidate
24 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii candidate
42 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JLOTION / TOPICAL111 mgExact identifier — unii candidate
42 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, COATED / ORAL488.7 mgExact identifier — unii candidate
10 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPAEROSOL, FOAM / TOPICAL240 mgExact identifier — unii candidate
19 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE / ORAL1488 mgExact identifier — unii candidate
27 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, ORALLY DISINTEGRATING / ORAL41 mgExact identifier — unii candidate
27 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
34 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9WAFER / ORAL22 mgExact identifier — unii candidate
10 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, DELAYED RELEASE / ORAL789.6 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / BUCCAL0.11 mgExact identifier — unii candidate
22 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOIL / AURICULAR (OTIC)419 mgExact identifier — unii candidate
19 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii candidate
10 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HPOWDER, FOR SOLUTION / ORAL270 mgExact identifier — unii candidate
24 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, DELAYED RELEASE / ORAL105 mgExact identifier — unii candidate
27 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HTABLET / SUBLINGUALNAExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE, DENTIFRICE / DENTAL1.4 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, COATED / ORAL7.93 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9TABLET, COATED / ORAL29.03 mgExact identifier — unii candidate
10 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE / ORAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8LOTION / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates

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
46a6b4cf-757c-4b86-b769-a772262f7d2997e8f493-917f-4cf4-ac1c-badb7e5b33aa2019-12-12WarningsExact identifier
spl set id: 97e8f493-917f-4cf4-ac1c-badb7e5b33aa

Reported adverse events (FAERS/openFDA)#

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