Label: PHILLIPS STOOL SOFTENER BULK DOCUSATE- docusate sodium capsule, liquid filled
- NDC Code(s): 0280-1012-30, 0280-1012-60
- Packager: Bayer HealthCare LLC.
- 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.
Updated October 31, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each softgel)
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you have
- stomach pain, nausea, or vomiting
- a sudden change in bowel habits that lasts over 14 days
Stop use and ask a doctor if
- you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
- take softgels with a full glass (8 oz) of water
adults and children 12 years and older take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses. children 6 to under 12 years take 1 softgel daily or as directed by a doctor children under 6 years of age ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 Capsule Carton
INGREDIENTS AND APPEARANCE
PHILLIPS STOOL SOFTENER BULK DOCUSATE
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1012 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) SODIUM HYDROXIDE (UNII: 55X04QC32I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color red Score no score Shape OVAL Size 4mm Flavor Imprint Code P10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-1012-30 1 in 1 CARTON 05/19/2015 1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:0280-1012-60 1 in 1 CARTON 05/19/2015 2 60 in 1 BOTTLE, PLASTIC; 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 09/02/2013 12/01/2023 Labeler - Bayer HealthCare LLC. (112117283)