Docusate Sod/Senna by Direct_Rx Docusate Sod/Senna

Docusate Sod/Senna by

Drug Labeling and Warnings

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

Drug Details [pdf]

DOCUSATE SOD/SENNA- docusate sod/senna tablet, film coated 
Direct_Rx

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Docusate Sod/Senna

Docusate Sodium 50 mg
Sennosides 8.6 mg

Stool softener

Stimulant laxative

Do not use

laxative products for longer than 1 week unless directed by a doctor
if you are presently taking mineral oil, 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 lasts over 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 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.

each tablet contains: calcium 20 mg, sodium 3 mg
store at controlled room temperature
Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
product of India

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

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 under 12 years of age ask a doctor

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

CLOSE

ask a health professional before use

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could

be signs of a serious condition.

relieves occasional constipation (irregularity)

this product generally produces bowel movement in 6 to 12 hours

DOCUSATE SOD/SENNA 
docusate sod/senna tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72189-378(NDC: 57896-304)
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	PSD21
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72189-378-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2022	10/16/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	09/09/2022	10/16/2023

Labeler - Direct_Rx (079254320)

Registrant - Direct_Rx (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
Direct_Rx		079254320	repack(72189-378)

Revised: 10/2023

Document Id: 07d9cb45-a5ba-a702-e063-6394a90a44a8

34390-5

Set id: e844057c-a7be-73d4-e053-2995a90ae9cb

Version: 3

Effective Time: 20231016