Label: DOCUSATE SODIUM capsule, liquid filled
- NDC Code(s): 24689-130-01
- Packager: APNAR PHARMA LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 9, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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 last 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 a signs of a serious condition.
- you need to use a stool softner laxative for more than 1 week
If pregnant or breast-feeding,
ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24689-130 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 GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color red Score no score Shape OVAL (Oblong) Size 13mm Flavor Imprint Code AD2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24689-130-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/25/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 09/25/2023 Labeler - APNAR PHARMA LP (079568229) Establishment Name Address ID/FEI Business Operations APNAR PHARMA LLP 118530917 analysis(24689-130) , manufacture(24689-130) , pack(24689-130)