Label: EXTRA STRENGTH STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 53808-0902-1 - Packager: State of Florida DOH Central Pharmacy
- This is a repackaged label.
- Source NDC Code(s): 0536-3757
- 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 March 3, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each softgel)
- Uses
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Warnings
Do not use
- if you are currently taking mineral oil, unless directed by a doctor
- when abdominal pain, nausea, or vomiting are present
- for more than 1 week, unless directed by a doctor
Ask a doctor before use if
you notice a sudden change in bowel habits that persists over a period of 2 weeks.
- Directions
- Other information
- Inactive Ingredients
-
Questions or comments?
1-800-645-2158
Distributed by: Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150
www.rugbylaboratories.comThis Product was Repackaged By:
State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
USA
And supplied by State of Florida DOH Central Pharmacy as follows:
NDC Strength Quantity/Form Color Source Prod. Code 53808-0902-1 250 MG 30 Capsules in a Blister Pack orange 0536-3757 - PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH STOOL SOFTENER LAXATIVE
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53808-0902(NDC:0536-3757) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 250 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 (orange) Score no score Shape OVAL (OVAL) Size 20mm Flavor Imprint Code P20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53808-0902-1 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 01/01/2014 Labeler - State of Florida DOH Central Pharmacy (829348114) Establishment Name Address ID/FEI Business Operations State of Florida DOH Central Pharmacy 829348114 repack(53808-0902)
