Docusate Sodium by Precision Dose, Inc. Docusate Sodium capsule

Drug Details [pdf]

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

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Docusate Sodium capsule

Drug Facts

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 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 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 25°C (59°F to 77°F).

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68094-052(NDC: 54629-601)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 68094-052-61	10 in 1 CARTON	09/30/2022	10/31/2024
1	NDC: 68094-052-59	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M007	09/30/2022	10/31/2024

Labeler - Precision Dose, Inc. (035886746)

Name	Address	ID/FEI	Business Operations
Establishment
Precision Dose, Inc.		035886746	REPACK(68094-052)

Revised: 1/2024

Document Id: ea85388c-b67d-4934-9c5a-c8453597b3b5

Set id: f8da3187-55d4-4e6f-a8ed-a0f76744e7ee

Version: 2

Effective Time: 20240112