DOCUSATE SODIUM capsule, liquid filled

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 250 mg

Purpose

Stool Softener

Uses

• For the relief of occasional constipation.
• Helps to prevent dry, hard stools.
• This product generally produces a bowel movement within 12 to 72 hours.

WARNINGS Do not use:

• If you are currently taking mineral oil, unless directed by a doctor.
• When abdominal pain, nausea, or vomiting are present.
• For longer than one week unless directed by a doctor.

Ask a doctor before use

if you notice a sudden change in bowel habits that persists over a period of two weeks.

Stop use and ask a doctor

if you have rectal bleeding or you fail to have a bowel movement after use.

If pregnant or breast-feeding,

ask a healthcare professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (800) 222-1222.

Directions

• Adults and Children over 12 years of age:

  Take orally 1 softgel preferably at bedtime for ; 2-3 days or until bowel movements are normal, or as directed by a doctor.

• Children under 12 years of age:

  Do not use this product for children under 12 years of age, unless directed by a doctor.

Other Information

• Each softgel contains 13 mg of Sodium.
• Store at room temperature between 15°C to 30°C (59°F to 86°F).
• Do not use if printed seal under cap is broken or missing.
• For identification purposes, each softgel will have an imprint that reads NV12.

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol.

Questions

Call 1 (800) 682-9862

Package/Label Principal Display Panel

Docusate Sodium, USP
Stool Softener
250 mg Each

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72789-166(NDC:54629-601)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	NV12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72789-166-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	05/01/2000	10/31/2027

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(72789-166)