DrugInserts.com: Trustworthy FDA Drug Information

Over the Counter Medications

Package Insert and Label Information: Docusate Sodium

By Bryant Ranch Prepack | Last revised: 22 January 2007

DOCUSATE SODIUM- docusate sodium capsule
Bryant Ranch Prepack

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 100 mg

Purpose

Stool softener

Uses

  • prevents/relieves dry hard stool
  • results usually occurs 1 to 3 days after the first dose

Warnings


Do not use

  • when abdominal pain, nausea, or vomiting are present
  • for more than one week unless directed by a doctor

Ask a doctor before use if you

  • are taking mineral oil
  • have noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

These could be signs of a serious condition
  • you have no bowel movement after 3 days
  • you have rectal bleeding

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

  • do not exceed recommended dose
adults and children over 12 years
take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
children 6 to 12 years
take 1 softgel daily
children under 6 years
consult a doctor

Inactive ingredients: D&C yellow #10, FD&C red #40, gelatin, glycerin, ink white, polyethylene glycol, sorbitol, propylene glycol.


Questions?

Adverse drug event call: (866) 562-2756

Docusate Sodium 100mg Capsule

Image File
(click image for full-size original)
DOCUSATE SODIUM
docusate sodium capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63629-1360(NDC:16103-384)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Docusate Sodium (Docusate) Docusate Sodium 100 mg
Inactive Ingredients
Ingredient Name Strength
D&C Yellow No. 10
FD&C Red No. 40
Gelatin
Glycerin
Polyethylene Glycol
Propylene Glycol
Sorbitol
Product Characteristics
Color red (Two-toned- white and clear red) Score no score
Shape OVAL Size 5mm
Flavor Imprint Code 51A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-1360-1 30 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:63629-1360-2 100 CAPSULE (CAPSULE) in 1 BOTTLE None
3 NDC:63629-1360-3 60 CAPSULE (CAPSULE) in 1 BOTTLE None
4 NDC:63629-1360-4 120 CAPSULE (CAPSULE) in 1 BOTTLE None
5 NDC:63629-1360-5 90 CAPSULE (CAPSULE) in 1 BOTTLE None
6 NDC:63629-1360-6 180 CAPSULE (CAPSULE) in 1 BOTTLE None
7 NDC:63629-1360-7 10 CAPSULE (CAPSULE) in 1 BOTTLE None
8 NDC:63629-1360-8 28 CAPSULE (CAPSULE) in 1 BOTTLE None
9 NDC:63629-1360-9 56 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 01/22/2007
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Accucaps Industries Ltd. 248441727 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK, RELABEL

Revised: 01/2007 Bryant Ranch Prepack