Label: DOCUSATE SODIUM capsule
- NDC Code(s): 0904-6998-60, 0904-6998-80
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 21, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that last over 2 weeks
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to the active ingredient in Colace® Regular Strength Stool Softener†
Docusate sodium 100 mg
Stool Softener Laxative
Softgels
†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
- Product Label
-
INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6998 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) SORBITAN (UNII: 6O92ICV9RU) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color orange Score no score Shape OVAL Size 12mm Flavor Imprint Code P51 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-6998-60 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2020 2 NDC:0904-6998-80 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 02/28/2020 Labeler - Major Pharmaceuticals (191427277)