Label: BASIC CARE STOOL SOFTENER- docusate sodium capsule, liquid filled
- NDC Code(s): 72288-486-78
- Packager: Amazon.com Services LLC
- 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.
Updated August 20, 2020
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- Active ingredient (in each softgel)
Ask a doctor before use if you have
- stomach pain
- noticed a sudden change in bowel habits that lasts over 2 weeks
Ask a doctor or pharmacist before use if you are
taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
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 signs of a serious condition.
- you need to use a laxative for more than 1 week
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
BASIC CARE STOOL SOFTENER
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-486 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 RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED, WHITE (to off beige) Score no score Shape OVAL (softgel) Size 13mm Flavor Imprint Code L486 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72288-486-78 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/14/2020 Labeler - Amazon.com Services LLC (128990418)