SENNOSIDES,DOCUSATE SODIUM tablet, film coated

Sennosides,Docusate sodium by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

PURPOSE

Purposes

Stool softener

Laxative

Uses

• relieves occasional constipation (irregularity) 
• generally produces bowel movement in 6-12 hours

WARNINGS

Do not use 

• 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 

• stomach pain 
• nausea
• vomiting 
• noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if 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, ask a health professional before use.

Keep out of reach of children.

In case of overdose, 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 of age or over	2 tablets once a day	4 tablets twice a day
  children 6 to under 12 years of age	1 tablet once a day	2 tablets twice a day
  children 2 to under 6 years of age	1/2 tablet once a day	1 tablets twice a day
  children under 2 years of age	ask a doctor	ask a doctor

Other information

• each tablet contains: calcium 11 mg 
• each tablet contains: sodium 4 mg
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT

croscarmellose sodium, dicalcium phosphate, FD&C yellow #5 lake*, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin

*contains FD&C yellow #5 lake (tartrazine) as a color additive.

Questions or comments?

(800) 616-2471

SPL UNCLASSIFIED SECTION

Tamper Evident: Do not use if sealed blister units are broken or damaged.

Product color may slightly vary due to natural changes of ingredients.

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

PRINCIPAL DISPLAY PANEL

NDC: 0904-6724-61

MAJOR

Unit Dose

SENNA PLUS TABLETS
(Stadardized Senna Concentrate & Docusate Sodium)

8.6/50 mg

100 Tablets

INGREDIENTS AND APPEARANCE

SENNOSIDES,DOCUSATE SODIUM 
sennosides,docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6724
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC;490
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6724-61	10 in 1 BOX	03/14/2019
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/14/2019

Labeler - Major Pharmaceuticals (191427277)