Docusate Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

Docusate Sodium

Cardinal Health

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Docusate Sodium 100 mg

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Each softgel contains: Docusate Sodium, 50% w/w in polyethylene glycol 400 (provides 100 mg Docusate Sodium)

Purpose

Stool Softener

Keep Out of Reach of Children

Keep this and all drugs out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center Immediately

Uses

Use as a stool softener for the temporary relief of occasional constipation. This product generally produces a bowel movement in 12 to 72 hours.

Warnings

This package is intended for institutional use only. Do not use the product if abdominal pain, nausea or vomiting are present.

Consult a physician before the use of this product.

Ask a doctor before use if: You have noticed a sudden change in bowel habits that persist over a period of 2 weeks. You are presently taking mineral oil.

Stop use and ask a doctor if: Rectal bleeding or failure to have a bowel movement occur after use, which may indicate a serious condition.

You need to use a laxative for more than 1 week.

If you are pregnant or breast-feeding, ask a health professional before use.

Directions

Adults and children 12 years of age and over. Take 1 to 3 softgels daily. Children 6 to under 12 years. Take 1 softgel daily. Children under 6 years consult a doctor.

Inactive ingredients

Gelatin, Polyethylene Glycol 400, Sorbitol SpecialTM(Sorbitol, sorbitol anhydrides, purified water and mannitol), Glycerin, Purified Water, Propylene Glycol, FD&C Red #40, FD&C Yellow #6, Edible white printing ink.

Sodium Content: 5 mg per softgel.

Storage

Store at 15-30 C (59-86 F)

Protect from excessive moisture.

SKY

Mfg. By: Banner Pharmacaps® High Point, NC USA 27265

Distributed By

McKesson Packaging Services

a business unit of McKesson Corporation

7101 Weddington Road

Concord, NC 28027

Validated with McKesson's PROmanager-Rx Automated storage & dispensing system for Package-Ready Oral solids

www.PROmanager-Rx.com

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Docusate Sodium 100 MG SOFGELSTM

STOOL SOFTENER

10 Softgels

Principal Display Panel

Docusate Sodium

Docusate Sodium CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-1477(NDC:63739-089)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 100 mg

Inactive Ingredients

Ingredient Name Strength
GELATIN
polyethylene glycol 400
sorbitol
water
mannitol
GLYCERIN
water
propylene glycol
FD&C RED NO. 40
FD&C YELLOW NO. 6

Product Characteristics

Color Size Imprint Code Shape
ORANGE (clear bright orange) 13 mm P51 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:55154-1477-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-02


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