Label: DOCUSATE SODIUM capsule
- NDC Code(s): 61919-525-60
- Packager: Direct_Rx
- This is a repackaged label.
- Source NDC Code(s): 0904-6457
- 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 September 13, 2019
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
Do not use
if you are presently taking mineral oil, unless told to do so by a doctor.
Ask a doctor before use if you have
noticed a sudden change in bowel habits that last over 2 weeks
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 a signs of a serious condition.
you need to use a laxative for more than 1 week
If pregnant or breast-feeding,
ask a health 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
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61919-525(NDC:0904-6457) 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) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) SORBITAN (UNII: 6O92ICV9RU) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color orange Score no score Shape OVAL Size 12mm Flavor Imprint Code P51;S77;SCU1;D2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-525-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/13/2019 Labeler - Direct_Rx (079254320) Registrant - Direct_Rx (079254320) Establishment Name Address ID/FEI Business Operations Direct_Rx 079254320 repack(61919-525)