Label: DOCUSATE SODIUM capsule, liquid filled
- NDC Code(s): 61919-459-60
- Packager: Direct_Rx
- This is a repackaged label.
- Source NDC Code(s): 0536-3756
- 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 January 20, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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
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
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61919-459(NDC:0536-3756) 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) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) GELATIN (UNII: 2G86QN327L) WATER (UNII: 059QF0KO0R) Product Characteristics Color orange ((orange)) Score no score Shape OVAL ((OVAL)) Size 13mm Flavor Imprint Code P51 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-459-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 08/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 08/14/2019 Labeler - Direct_Rx (079254320) Registrant - Direct_Rx (079254320) Establishment Name Address ID/FEI Business Operations Direct_Rx 079254320 repack(61919-459)