NDC | 52327-011-10, 52327-011-11 |
Set ID | 050c6139-344b-47d4-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Aidapak Services, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART334 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- PREGNANCY OR BREAST FEEDING
- INFORMATION FOR PATIENTS
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
-
INGREDIENTS AND APPEARANCE
EXTRA STRENGTH STOOL SOFTENER LAXATIVE
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52327-011(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 in 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 Score no score Shape OVAL Size 20mm Flavor Imprint Code P20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52327-011-11 100 in 1 BLISTER PACK 10/20/2014 1 NDC:52327-011-10 1 mg in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/20/2014 Labeler - Aidapak Services, LLC (831612457) Registrant - Aidapak Services, LLC (831612457) Establishment Name Address ID/FEI Business Operations Aidapak Services, LLC 831612457 relabel(52327-011)