SENNA WITH DOCUSATE SODIUM- docusate sodium and sennosides tablet

SENNA WITH DOCUSATE SODIUM by

Drug Labeling and Warnings

SENNA WITH DOCUSATE SODIUM by is a Otc medication manufactured, distributed, or labeled by HHH Pharmaceuticals, Elysium Pharmaceuticals Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)                    Purpose

Docusate sodium 50 mg.......................................Stool softner

Sennosides 8.6 mg................................................Laxative

Uses

• relieves occasional constipation (irregularity)
• generally causes 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 and over	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years	½ tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask a doctor

Other information

• each tablet contains: calcium 21 mg, sodium 3 mg. VERY LOW SODIUM
• store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
• DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, polyethylene glycol, FD&C red 40 lake, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid powder, titanium dioxide.

Questions or comments?

call toll-free 1-302-380-3408

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNA WITH DOCUSATE SODIUM 
docusate sodium and sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83586-001
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S44
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83586-001-00	50000 in 1 DRUM; Type 0: Not a Combination Product	10/07/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	10/07/2025

Labeler - HHH Pharmaceuticals (144848997)

Registrant - HHH Pharmaceuticals (144848997)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd		863182240	manufacture(83586-001)

Establishment
Name	Address	ID/FEI	Business Operations
HHH Pharmaceuticals		144848997	pack(83586-001)