Docusate Sodium by PD-Rx Pharmaceuticals, Inc. DOCUSATE SODIUM capsule

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by PD-Rx Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

• relieves occasional constipation (irregularity)
• results usually occurs 1 to 3 days after the first dose
  

Warnings

Do not use

Do not use if you are currently taking mineral oil, unless directed bya doctor

Ask a doctor before use if you

• stomach pain, nausea or vomiting
• have noticed a sudden change in bowel habits that last over 2 weeks
  

Stop use and ask a doctor if

• you have rectal bleeding
• you fail to have a bowel movement after use

you need to use a stool softner laxative for more than 1 week

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

• do not exceed recommended dose

• adults and children over 12 years and older: take 1-3 softgels daily
• children 2 to 12 years of age: take 1 softgel daily
• children under 2 years: ask a doctor

Other information

• Each capsule contains sodium 6mg
• store at room temperature 15 o to 30 oC (59 o to 86 oF)
• protect from moisture
  

Inactive ingredients: FD&C Red #33,Edible Ink,FD&C Red #40,FD&C Yellow #6, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol Special.

Questions?

Adverse drug event call: (866) 562-2756

HOW SUPPLIED

Supplied in bottles of 14, 30, 60, 90 and 180 softgels.

Principal Display Panel

*Compare to the active ingredient of Colace®

Docusate Sodium

Stool Softener

100 mg each

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55289-493
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red (Two-toned- white and clear red)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SC02
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55289-493-14	14 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2018
2	NDC: 55289-493-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2018
3	NDC: 55289-493-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2018
4	NDC: 55289-493-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2018
5	NDC: 55289-493-93	180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/12/2018	01/31/2038

Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)

Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)

Establishment
Name	Address	ID/FEI	Business Operations
PD-Rx Pharmaceuticals, Inc.		156893695	repack(55289-493)