Label: DOCUSATE SODIUM capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 68210-0402-1, 68210-0402-2, 68210-0402-3, 68210-0402-4, view more68210-0402-5 - Packager: SPIRIT PHARMACEUTICALS,LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 20, 2009
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient(in each capsule)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
- Directions
- Inactive ingredients
- QUESTIONS
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PRINCIPAL DISPLAY PANEL
Docusate Sodium capsules USP 50mg
Each Softgel Contains:
(Docusate Sodium USP 50mg)LOT NO :
DRUM NO :
MFG DATE :
QUANTITY :
NDC NO : 68210-0402-
EXP DATE :
WARNING:
KEEP OUT OF REACH OF CHILDRENSTORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZINGTHIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C. ACT AND REGULATIONS THEREUNDER.MANUFACTURED BY:
SOFTGEL HEALTHCARE PVT LIMITED
INDIA
LABELLER CODE : 35916
LIC NO. : TN/DRUGS/00002124MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
- 1 – 10
- 2 – 30
- 3 – 100
- 4 – 1000
- 5 – 16000
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0402 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) GLYCERIN (UNII: PDC6A3C0OX) GELATIN (UNII: 2G86QN327L) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Product Characteristics Color RED Score no score Shape OVAL Size 10mm Flavor Imprint Code DO4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-0402-1 1 in 1 BOX 1 10 in 1 BAG 2 NDC:68210-0402-2 1 in 1 BOX 2 30 in 1 BAG 3 NDC:68210-0402-3 1 in 1 BOX 3 100 in 1 BAG 4 NDC:68210-0402-4 1 in 1 BOX 4 1000 in 1 BAG 5 NDC:68210-0402-5 1 in 1 BOX 5 16000 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part310.545 10/01/2009 Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011) Establishment Name Address ID/FEI Business Operations SOFTGEL HEALTHCARE PVT LTD 675584180 MANUFACTURE