Label: DOCUSATE SODIUM capsule, liquid filled
Contains inactivated NDC Code(s)
NDC Code(s): 61919-459-30, 61919-459-71
- 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.
Updated May 14, 2015
If you are a consumer or patient please visit this version.
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- INDICATIONS & USAGE SECTION
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 SECTION
adults and children over 12 years of age take 1 to 3 softgels preferably at bedtime children 6-12 years of age take 1 softgel at bedtime children under 6 years ask a doctor
- each softgel contains: sodium 6 mg
- store between 15º-30ºC (59º-86ºF)
Questions or comments?
Principal Display Panel
COMPARE TO ACTIVE INGREDIENT IN COLACE®*
Stool Softener Laxative
Docusate Sodium USP, 100 mg
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Rugby Laboratories is not affiliated with the owner of the trademark Colace®.
Distributed by: Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- INACTIVE INGREDIENT SECTION
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 FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color orange Score no score Shape OVAL Size 13mm Flavor Imprint Code P51 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-459-71 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:61919-459-30 30 in 1 BOTTLE; 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 01/01/2014 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 relabel(61919-459)