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 250 mg

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

In each softgel: Docusate Sodium 250 mg

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 right away. This unit dose package is not child resistant.

Uses

For the prevention of dry, hard stools and for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

Warnings

This package is intended for institutional use only. If pregnant or breast-feeding, ask a health professional before use.

Do not use if you are currently taking mineral oil, unless directed by a doctor, when abdominal pain, nausea, or vomiting are present or for more 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 2 weeks.

Stop use and ask a doctor if you have rectal bleeding or if you fail to have a bowel movement after use.

Directions

  • Adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
  • Children under 12 years of age: take as directed by a doctor

Inactive ingredients

Edible white printing ink, FD&C red #40, FD&C Yellow #6, gelatin, glycerin USP, polyethylene glycol USP, propylene glycol USP, purified water USP, Sorbitol SpecialTM (Sorbitol, sorbitol anhydrides, purified water, and mannitol).

Storage

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

Each softgel contains: sodium 13.802 mg very low sodium

Do not use if blister units are torn, broken or show any signs of tampering.

Manufactured by:

Banner Pharmacaps Inc.

High Point, NC 27265

Distributed by:

UDL LABORATORIES, INC.

ROCKFORD, IL 61103

Questions? 1-800-848-0462

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Docusate Sodium Softgel

250 mg

Stool Softener

10 Softgels

Principal Display Panel

Docusate Sodium

Docusate Sodium CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-5474(NDC:51079-048)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 250 mg

Inactive Ingredients

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

Product Characteristics

Color Size Imprint Code Shape
ORANGE (clear bright orange) 13 mm P20 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:55154-5474-0 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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