Senna/Docusate Sodium by Major Pharmaceuticals Senna-S

Senna/Docusate Sodium by

Drug Labeling and Warnings

Senna/Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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/DOCUSATE SODIUM 
docusate sodium and sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5512(NDC: 0182-1113)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	ORANGE	Score	no score
Shape	ROUND (bi-convex)	Size	10mm
Flavor		Imprint Code	CPC;490
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5512-61	100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	06/16/2011	08/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/16/2011	08/30/2016

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
Major Pharmaceuticals		191427277	REPACK(0904-5512)

Revised: 12/2019

Document Id: 46a6b4cf-757c-4b86-b769-a772262f7d29

34390-5

Set id: 97e8f493-917f-4cf4-ac1c-badb7e5b33aa

Version: 6

Effective Time: 20191212

 

Major Pharmaceuticals