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Docusate Sodium: Package Insert / Prescribing Info

Package insert / product label
Dosage form: capsule, liquid filled
Drug class: Laxatives

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

Active ingredient (in each capsule)

Docusate Sodium, USP 100mg

Purpose

Stool Softener

Indications and Usage for Docusate Sodium

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

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 2 weeks.

Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use.

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.

Docusate Sodium Dosage and Administration

  • Adults and children over 12 years of age: Take orally 1 to 2 softgels at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
  • Children 6-12 years of age: Take orally softgels 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 us this product for children under 6 years of age, unless directed by a doctor.

Other information

  • Each capsule contains 5 mg of Sodium.
  • Store at room temperature 15° - 30°C (59° - 86°F).

Inactive ingredients

FD&C Red #40, Gelatin, Glycerin, Polyethylene Glycol 400, Sorbitol Special, FD&C Yellow #6 and Purified Water.

Manufactured & Distributed by:

Swiss Caps USA, Inc.

Miami, FL 33186

Repackaged by:

American Health Packaging

Columbus, OH 43217

Package Label - Principal Display Panel

Docusate Sodium, USP 100 mg capsule
DOCUSATE SODIUM
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62584-683
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
WATER (UNII: 059QF0KO0R)
Product Characteristics
Colorred (Reddish) Scoreno score
ShapeOVALSize12mm
FlavorImprint CodeSCU1
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62584-683-01100 in 1 CARTON
1NDC:62584-683-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/08/201004/30/2017
Labeler - American Health Packaging (929561009)
Establishment
NameAddressID/FEIBusiness Operations
SWISS CAPS USA, INC.033105888manufacture(62584-683)
Establishment
NameAddressID/FEIBusiness Operations
American Health Packaging929561009repack(62584-683)

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