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 laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

if you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that last 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 a signs of a serious condition.
• you need to use a 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 (1-800-222-1222)  right away.

Directions

• take only by mouth. Doses may be taken as a single daily dose or in divided doses.

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

Other information

• each softgel contains:sodium 5 mg
• store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

Questions or comments?

 Call 1-800-616-2471

Principal Display Panel

Docusate sodium 100 mg is a orange oval softgel with imprint P51.

NDC: 72789-274-30 Bottles of 30 softgels

Compare to the active ingredient in Colace ®Regular Strength Stool Softener†

Docusate sodium 100 mg

Stool Softener Laxative

Softgels

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.

TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLE.

Distributed by:

Docusate Sodium 100 mg

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72789-274(NDC:0904-6998)
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
SORBITAN (UNII: 6O92ICV9RU)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	P51
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72789-274-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/11/2022	10/28/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	02/28/2020	10/28/2025

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(72789-274)