DOCUSATE SODIUM AND SENNOSIDES capsule, liquid filled

Docusate Sodium and Sennosides by

Drug Labeling and Warnings

Docusate Sodium and Sennosides by is a Otc medication manufactured, distributed, or labeled by SOFTGEL HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

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 movements 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 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 accidental overdose, seek professional assistance 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 older	2 softgels once a day	4 softgels twice a day
  children 6 to 12 years of age	1 softgel once a day	2 softgels twice a day
  children under 6 years of age	ask a doctor	ask a doctor

Other information

• each softgel contains: Sodium 3 mg
• store at 25°C (77°F); excursions permitted between 15°- 30°C (59°- 86°F)

Inactive ingredients

Propylene glycol, Povidone, Colloidal Silicon Dioxide, Yellow wax, Polyethylene glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD&C Red No.40, Titanium dioxide and Purified water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM AND SENNOSIDES 
docusate sodium and sennosides capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-0449
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
POVIDONE K30 (UNII: U725QWY32X)
YELLOW WAX (UNII: 2ZA36H0S2V)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITOL (UNII: 506T60A25R)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
1,4-SORBITAN (UNII: AV0YTZ4E6J)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red ((Opaque))	Score	score with uneven pieces
Shape	OVAL	Size	5mm
Flavor		Imprint Code	903
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-0449-2	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	04/22/2024

Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED		675584180	manufacture(35916-0449)