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Docusate Sodium by National Vitamin Company

Medically reviewed on December 29, 2017

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: National Vitamin Company
NDC Code: 54629-600

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.

Docusate Sodium, USP
Stool Softener

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener

Uses
For the relief of occasional constipation.
Helps to prevent dry, hard stools.
This product generally produces a bowel movement within 12 to 72 hours.

WARNINGS Do not use:
If you are currently taking mineral oil, unless directed by a doctor.
When abdominal pain, nausea, or vomiting are present.
For longer 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 two weeks.

Stop use and ask a doctor

if you have rectal bleeding or you fail to have a bowel movement after use.

If you are pregnant or breast-feeding,

ask a healthcare 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

Adults and Children over 12 years of age

Take orally 1 to 2 softgels preferably at bedtime for
2-3 days or until bowel movements are normal, or as directed by a doctor.

Children 6 to 12 years of age

Take orally 1 softgel preferably at bedtime for
2-3 days or until bowel movements are normal, or as directed by a doctor.

Children under 6 years of age

Do not use this product for children under 6 years of age, unless directed by a doctor.

Other Information
Each softgel contains 5 mg of Sodium.
Keep lid tightly closed.
Store at room temperature between 15°C to 30°C (59°F to 86°F).
Do not use if printed seal under cap is broken or missing.
For identification purposes, each softgel will have an imprint that reads NV13.

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol.

Package/Label Principal Display Panel

NDC 54629-600-01
Life-Line®
DOCUSATE SODIUM, USP
STOOL SOFTENER
100 mg Each
100 Softgels

Manufactured and Distributed by
National Vitamin Company
Casa Grande, AZ 85122

Bottle Label

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54629-600
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN, UNSPECIFIED 
GLYCERIN 
POLYETHYLENE GLYCOL 1000 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize12mm
FlavorImprint CodeNV13
Contains    
Packaging
#Item CodePackage Description
1NDC:54629-600-01100 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:54629-600-991000 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/2000
Labeler - National Vitamin Company (102098324)
Establishment
NameAddressID/FEIOperations
National Vitamin Company102098324MANUFACTURE(54629-600)
Establishment
NameAddressID/FEIOperations
SWISSCAPS Romania srl565466997MANUFACTURE(54629-600)

 
National Vitamin Company

← See all Docusate Sodium brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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