Label: DOCUSATE SODIUM 100MG- docusate sodium capsule
- NDC Code(s): 45861-076-01
- Packager: Pharmaceutica North America, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 10, 2025
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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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
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 stool softener laxative for more than 1 week
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. - KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive Ingredients
- Questions or comments? 1-888-788-6472
- Product label
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM 100MG
docusate sodium capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45861-076 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) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color red Score no score Shape ROUND Size 13mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45861-076-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 02/01/2025 Labeler - Pharmaceutica North America, Inc. (962739699)