OTC Medication Information: Docusate Sodium

DOCUSATE SODIUM- docusate sodium capsule, liquid filled
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool Softener

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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 you are pregnant or breast-feeding,

ask a healthcare professional before use.

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).
For identification purposes, each softgel will have an imprint that reads NV12.
Bend at perforation before tearing

Inactive ingredients

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

Questions

Call 1-855-361-3993

Generic Section

Manufactured for

AvKARE

Pulaski, TN 38478

AVPAK™

A PRODUCT OF AvKARE

Made in USA

Mfg. Formula 8064

Distributed by:

Cardinal Health

Dublin, OH 43017

L5365630-10721

Principal Display Panel

Docusate Sodium, USP

Stool Softener

250 mg

10 Softgels

bag label
(click image for full-size original)
DOCUSATE SODIUM
docusate sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-4341(NDC:50268-268)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 250 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
GLYCERIN
POLYETHYLENE GLYCOL 1000
PROPYLENE GLYCOL
WATER
SORBITOL
Product Characteristics
Color red Score no score
Shape OVAL Size 20mm
Flavor Imprint Code NV12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-4341-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the BAG (55154-4341-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 05/17/2017
Labeler — Cardinal Health (603638201)

Revised: 07/2021 Cardinal Health

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.