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
Stimulant laxative

Uses

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

WARNINGS

• laxative products for longer than 1 week unless told to do so by a doctor
• if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that lasts over two 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 could be signs of 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 only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
  • adults and children 12 years and over: take 2-4 tablets daily
  • children 6 to under 12 years of age: take 1-2 tablets daily
  • children 2 to under 6 years of age: take up to 1 tablet daily
  • children under 2 years: ask a doctor

OTHER SAFETY INFORMATION

• each tablet contains: calcium 5 mg
• Store in a dry place at 15° – 30°C (59° – 86°F).

INACTIVE INGREDIENT

corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide.

QUESTIONS

Questions or comments? 1-800-231-4670

SPL UNCLASSIFIED SECTION

Keep this carton for complete product information

Tamper Evident:

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

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com

PRINCIPAL DISPLAY PANEL

Major

NDC: 0904-7440-61

Unit Dose

Sennosides/Docusate Sodium

8.6mg/50mg

Stool Softener/Stimulant Laxative

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: 0904-7440
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
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TALC (UNII: 7SEV7J4R1U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	49;0
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7440-61	10 in 1 BOX, UNIT-DOSE	05/01/2024
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 Drug	M007	05/01/2024

Labeler - Major Pharmaceuticals (191427277)