Label: DOCUSATE SODIUM tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 61919-888-30, 61919-888-60, 61919-888-71 - Packager: Direct Rx
- This is a repackaged label.
- Source NDC Code(s): 0603-0150
- 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 November 4, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- INDICATIONS & USAGE SECTION
- OTC - DO NOT USE SECTION
- OTC - ASK DOCTOR SECTION
- OTC - STOP USE SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- DOSAGE & ADMINISTRATION SECTION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT SECTION
- SPL UNCLASSIFIED SECTION
- WARNINGS SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61919-888(NDC:0603-0150) 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) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red (Reddish) Score no score Shape capsule Size 12mm Flavor Imprint Code SCU1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-888-71 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:61919-888-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2015 3 NDC:61919-888-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2015 Labeler - Direct Rx (079254320) Establishment Name Address ID/FEI Business Operations Direct Rx 079254320 relabel(61919-888) , repack(61919-888)