OTC Medication Information: Docusate Sodium

DOCUSATE SODIUM- docusate sodium capsule, liquid filled
NCS HealthCare of KY, LLC dba Vangard Labs

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool Softener Laxative

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

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

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 (1-800-222-1222).

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 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years

ask a doctor

Other information

  • each softgel contains: sodium 6 mg
  • very low sodium
  • store at 20-25°C (68-77°F)

Inactive ingredients

D&C red no. 33, edible ink, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-800-719-9260

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DOCUSATE SODIUM
docusate sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-8041(NDC:45802-486)
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 RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
SORBITAN
SORBITOL
TITANIUM DIOXIDE
PROPYLENE GLYCOL
Product Characteristics
Color red, white (to off beige) Score no score
Shape OVAL (softgel) Size 13mm
Flavor Imprint Code L486
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-8041-39 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK None
2 NDC:0615-8041-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
2 5 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (0615-8041-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug 505G(a)(3) 10/28/2008
Labeler — NCS HealthCare of KY, LLC dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, LLC dba Vangard Labs 050052943 repack (0615-8041)

Revised: 12/2023 NCS HealthCare of KY, LLC dba Vangard Labs

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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