SENNA/DOCUSATE SODIUM- docusate sodium and sennosides tablet, film coated 
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Senna-S

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)

Standardized Senna Concentrate, Sennosides 8.6 mg

Sodium Dioctylsulfosuccinate 50mg

Purpose

Purposes

 Standardized Senna Concentrate, Sennosides 8.6 mg

laxative 

  Sodium Dioctylsulfosuccinate 50 mg

  Stool softener

Uses

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

Warnings

Do not use

•
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

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

Stop use and ask a doctor if you have

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

ask a health professional before use.

Keep out of the reach of children

In case of overodse, get medical help or contact a Poison Control Center right away.

Directions

•
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

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

Other Ingredients

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?

Adverse Drug Event Call (800) 616-2471

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

 SENNA PLUS TABLETS 8.6/50 MG

SENNA/DOCUSATE SODIUM 
docusate sodium and sennosides tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5512(NDC:0182-1113)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUND (bi-convex) Size10mm
FlavorImprint Code CPC;490
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5512-61100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product06/16/201108/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/16/201108/30/2016
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
Major Pharmaceuticals191427277REPACK(0904-5512)

Revised: 12/2019
Document Id: 46a6b4cf-757c-4b86-b769-a772262f7d29
Set id: 97e8f493-917f-4cf4-ac1c-badb7e5b33aa
Version: 6
Effective Time: 20191212
 
Major Pharmaceuticals