Label: DOCUSATE SODIUM capsule, liquid filled
- NDC Code(s): 53345-035-01
- Packager: Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
- 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 November 8, 2019
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)
- Purpose
- Uses
-
Warnings
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that last over 2 weeks
- Directions
- Other information
- Inactive Ingredients
-
Principal Display Panel - Shipping Label
Docusate Sodium Capsules
250 mg
NDC 53345-035-01
7000 Capsules
IMPORTANT:
1.Inspect immediately upon receipt.
2.This is a bulk shipment, intended for further processing only.
3.Protect from heat, humidity, and light. Do not refrigerate.
4.Store at 15-30°C (59-86°F)CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
-
INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-035 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red (clear) Score no score Shape capsule (oblong) Size 20mm Flavor Imprint Code P4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53345-035-01 1 in 1 BOX 02/10/2016 1 7000 in 1 BAG; 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 02/10/2016 Labeler - Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd (421293287) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd 421293287 manufacture(53345-035) , analysis(53345-035)