DOCUSATE SODIUM by Cellchem Pharmaceutical Inc / Softgel Healthcare Private Limited DOCUSATE SODIUM capsule

DOCUSATE SODIUM by

Drug Labeling and Warnings

DOCUSATE SODIUM by is a Otc medication manufactured, distributed, or labeled by Cellchem Pharmaceutical Inc, Softgel Healthcare Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each capsule)                         Purpose

Docusate sodium 100 mg................................................Laxative, stool softener

PURPOSE

Stool Softener

Uses

• Relief of occasional constipation 
• softens the stools

Warnings

Do not use

• if you have
  • abdominal pain
  • nausea
  • fever
  • vomiting
• with other medicines or if you are presently taking mineral oil
• if you are on a low salt diet
• longer than 7 days

When using this product

• frequent or prolonged use may result in dependence on laxatives
• it may take up to 3 days for you to have a bowel movement

Stop use and ask a doctor if

• rectal bleeding occurs
• symptoms persist, last for more than 7 days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, call a poison control centre or get medical help right away, even if you do not notice any signs or symptoms. 

Directions

• Adults and children 12 years and over: 
• Take 1 - 2 capsules daily or as directed by physician 
• Do not take more than 4 capsules per day.
• Drink lots of fluids (one full glass or more)

Other information

• Questions ?

1(844) 481-8884

Inactive ingredients

Polyethylene glycol 400, propylene glycol, gelatin, glycerin, sodium methyl paraben, sodium propyl paraben, sorbitol sorbitan solution, purified water, FD&C Red No. 40, FD&C Yellow No. 6.

SPL UNCLASSIFIED SECTION

Manufactured for :
CellChem Pharmaceuticals Inc.
Ottawa, ON, Canada K2E 7V7

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73147-8273
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red (Dark Red)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73147-8273-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	10/10/2023

Labeler - Cellchem Pharmaceutical Inc (111518618)

Establishment
Name	Address	ID/FEI	Business Operations
Softgel Healthcare Private Limited		675584180	manufacture(73147-8273)