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

Docusate Sodium

Rebel Distributors Corp

  • 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 Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Docusate Sodium 100mg

Purpose

Stool Softener

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control center right way.

Uses

Prevents / relieves dry hard stool. Results usually occur 1 to 3 days after the first dose.

Warnings

Do not use for more than one week unless directed by a doctor.

Ask a doctor before use if you have abdominal pain, nausea, or vomiting; have noticed a sudden change in bowel habits that lasts over 2 weeks,; are taking mineral oil.

Stop use and ask a doctor if you have no bowel movement within 3 days; you have rectal bleeding. These could be signs of a serious condition.

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

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Directions

Adults and children 12 years and older: take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by a doctor.

Children under 12: consult a doctor.

Do not exceed recommended dose.

Other Information

Each softgel contains sodium 5mg.

Product from Canada or USA

Store at room temperature, 15°C-30°C (59°F-86°F)

Inactive ingredients

may contain cirtic acid, D&C red no. 33, D&C yellow no. 10, ethyl vanillin, FD&C blue no. 1, FD&C re no. 40 FD&C yellow no. 6, gelatin, glycerin, edible ink, mannitol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, sorbitol, water.

Distributed by:

Geri-Care Pharmaceuticals Corp.

Brooklyn, NY 11204

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Package/Label Principal Display Panel

Package/Label Principal Display Panel

Docusate Sodium

Docusate Sodium CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21695-590(NDC:57896-401)
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
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
D&C YELLOW NO. 10
ETHYL VANILLIN
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
mannitol
METHYLPARABEN
polyethylene glycol
propylene glycol
PROPYLPARABEN
sorbitol
water

Product Characteristics

Color Size Imprint Code Shape
RED 14 mm A92 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21695-590-20 20 in 1 BOTTLE
2 NDC:21695-590-30 30 in 1 BOTTLE
3 NDC:21695-590-90 90 in 1 BOTTLE
4 NDC:21695-590-00 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2007-01-01


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