Label: DOCUSATE SODIUM capsule, liquid filled
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NDC Code(s):
63739-478-01,
63739-478-02,
63739-478-10,
63739-478-40, view more63739-478-48
- Packager: McKesson Corporation
- This is a repackaged label.
- Source NDC Code(s): 61301-8001
- 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 August 23, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Uses
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Warnings
Do not use
- if you are currently taking mineral oil, unless directed by a doctor
- when abdominal pain, nausea, or vomiting are present
- for longer than 1 week unless directed by a doctor
Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.
Stop use and ask a doctor if
- you have rectal bleeding
- you fail to have a bowel movement after use
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- HOW SUPPLIED
- Docusate Sodium
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63739-478(NDC:61301-8001) 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) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) WATER (UNII: 059QF0KO0R) Product Characteristics Color red (Reddish) Score no score Shape OVAL Size 12mm Flavor Imprint Code SCU1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63739-478-01 25 in 1 BOX, UNIT-DOSE 11/09/2010 02/28/2016 1 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63739-478-10 10 in 1 BOX, UNIT-DOSE 11/09/2010 02/28/2016 2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:63739-478-48 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/19/2017 09/21/2017 4 NDC:63739-478-40 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/19/2017 09/21/2017 5 NDC:63739-478-02 30 in 1 BOX, UNIT-DOSE 07/01/2021 5 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 11/09/2010 Labeler - McKesson Corporation (140529962) Establishment Name Address ID/FEI Business Operations Contract Packaging Resources Inc. 960203917 repack(63739-478)
