1. Home
  2. Labeler Index
  3. Spirit Pharmaceuticals,llc
  4. 68210-0401
  5. Label Information: Docusate Sodium

FDA Label for Docusate Sodium

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPSULE)
    2. PURPOSE
    3. USES
    4. DIRECTIONS
    5. INACTIVE INGREDIENTS
    6. PRINCIPAL DISPLAY PANEL

Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals,llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Capsule)



Docusate sodium 100 mg


Purpose



Stool softener


Uses



  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Directions



  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
    • adults and children 12 years and overtake 1-3 capsules daily
    children 2 to under 12 years of agetake 1 capsule daily
    children under 2 yearsask a doctor

Inactive Ingredients



D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methylparaben, PEG 400, propylene glycol, propylparaben, sorbitol, titanium dioxide


Principal Display Panel



Docusate Sodium capsules USP 100mg

Each Softgel Contains:
(Docusate Sodium USP 100mg)

LOT NO:QUANTITY:
DRUM NO:NDC NO: 68210-0401-*
MFG DATE:EXP DATE:

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° – 86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS 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/00002124

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

* Please review the disclaimer below.