DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Precision Dose, Inc.

----------

Docusate Sodium capsule

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool Softener

Uses

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 noticed 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.
  • You fail to have a bowel movement after use.

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

Adult and Children over 12 years of ageTake 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 ageDo not use this product for children under 12 years of age, unless directed by a doctor.

Other information

Inactive ingredients

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

How Supplied

NDC 68094-052-61
Unit Dose Packages of 100 Softgels (10×10) per Carton

Distributed by:
National Vitamin Company
Casa Grande, AZ 85122

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

LI1459 Rev. 06/21

PRINCIPAL DISPLAY PANEL - 250 mg Softgel Blister Pack Carton

Precision Dose™

NDC 68094-052-61
Unit Dose

Docusate Sodium, USP
250 mg Softgels

100 Softgels
(10 x 10)

(in each softgel)
Docusate Sodium 250 mg Stool Softener

Each softgel contains 13 mg of Sodium.

USUAL DOSE: SEE ENCLOSED INSERT.

Store at room temperature between
15°C to 25°C (59°F to 77°F).

Keep out of reach of children.

Hospital Use Only.

LC1458
R0

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 250 mg Softgel Blister Pack Carton
DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-052(NDC:54629-601)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeOVALSize20mm
FlavorImprint Code NV12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68094-052-6110 in 1 CARTON09/30/202210/31/2024
1NDC:68094-052-5910 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM00709/30/202210/31/2024
Labeler - Precision Dose, Inc. (035886746)
Establishment
NameAddressID/FEIBusiness Operations
Precision Dose, Inc.035886746REPACK(68094-052)

Revised: 1/2024
Document Id: ea85388c-b67d-4934-9c5a-c8453597b3b5
Set id: f8da3187-55d4-4e6f-a8ed-a0f76744e7ee
Version: 2
Effective Time: 20240112
 
Precision Dose, Inc.