DOCUSATE SODIUM AND SENNOSIDES capsule, gelatin coated

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

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.

PREGNANCY OR BREAST FEEDING

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 older	2 softgels once a day	4 softgels twice a day
  children 6 to 12 years	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

colloidal silicon dioxide, FD&C yellow no.6, gelatin, glycerin, polyethylene glycol 400, povidone K 30, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide, yellow wax

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM AND SENNOSIDES 
docusate sodium and sennosides capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-0453
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
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (opaque)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	902
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-0453-1	500 in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2024
2	NDC: 35916-0453-3	2 in 1 BOX	06/12/2025
2		3000 in 1 POUCH; 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	06/04/2024

Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (676666501)