DOCUSATE SODIUM description, usages, side effects, indications, overdosage, supplying and lots more!

DOCUSATE SODIUM

SPIRIT PHARMACEUTICALS,LLC

  • 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 capsules USP 100mg

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each capsule)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

  • if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

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

  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over take 1-3 capsules daily
children 2 to under 12 years of age take 1 capsule daily
children under 2 years ask a doctor

Inactive ingredients

D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methylparaben, PEG 400, propylene glycol, propylparaben, sorbitol, titanium dioxide

PRINCIPAL DISPLAY PANEL

Docusate Sodium capsules USP 100mg

Each Softgel Contains:
(Docusate Sodium USP 100mg)

LOT NO : QUANTITY :
DRUM NO : NDC NO : 68210-0401-*
MFG DATE : EXP DATE :

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° – 86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.

MANUFACTURED BY:
SOFTGEL HEALTHCARE PVT LIMITED
INDIA
LABELLER CODE             : 35916
LIC NO.                              : TN/DRUGS/00002124

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

  • 1 - 10
  • 2 - 30
  • 3 - 100
  • 4 - 1000
  • 5 - 16000
  • 6 - 20000
PRINCIPAL DISPLAY PANEL

DOCUSATE SODIUM

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68210-0401
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
polyethylene glycol 400
GLYCERIN
GELATIN
sorbitol
water
D&C RED NO. 33
FD&C RED NO. 40
FD&C YELLOW NO. 6

Product Characteristics

Color Size Imprint Code Shape
RED 10 mm DO4 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68210-0401-1 10 in 1 BOX
2 NDC:68210-0401-2 30 in 1 BOX
3 NDC:68210-0401-3 100 in 1 BOX
4 NDC:68210-0401-4 1000 in 1 BOX
5 NDC:68210-0401-5 16000 in 1 BOX
6 NDC:68210-0401-6 20000 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-03-01


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Be sure to consult your doctor before taking any medication!
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