Label: DOCUSATE SODIUM capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 67046-140-30, 67046-140-60 - Packager: Contract Pharmacy Services-PA
- This is a repackaged label.
- Source NDC Code(s): 16103-384
- Category: HUMAN OTC DRUG LABEL
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 April 22, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Uses
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Warnings
Do not use
- when abdominal pain, nausea, or vomiting are present
- for more than one week unless directed by a doctor
Ask a doctor before use if you
- are taking mineral oil
- have noticed a sudden change in bowel habits that last over 2 weeks
- Directions
- Other information
- Inactive ingredients: D&C yellow #10, FD&C red #40, gelatin, glycerin, ink white, polyethylene glycol, sorbitol, propylene glycol.
- Questions?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67046-140(NDC:16103-384) 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red (Two-toned- white and clear red) Score no score Shape OVAL Size 5mm Flavor Imprint Code 51A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67046-140-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 04/15/2012 2 NDC:67046-140-60 60 in 1 BLISTER PACK; Type 0: Not a Combination Product 04/16/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/22/2007 Labeler - Contract Pharmacy Services-PA (945429777) Establishment Name Address ID/FEI Business Operations Coupler Enterprises Inc. 945429777 repack(67046-140)