Docusate Sodium Capsules Usp 50 Mg

Docusate Sodium Capsules Usp 50 Mg
SPL v1
SPL
SPL Set ID 0ecd8576-5bc4-45ca-86d8-e6b73ef5aace
Route
ORAL
Published
Effective Date 2009-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg)
Inactive Ingredients
Polyethylene Glycol 400 Glycerin Gelatin Sorbitol Water Propylene Glycol D&c Red No. 33

Identifiers & Packaging

Pill Appearance
Imprint: DO4 Shape: oval Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-10-01

Description

Docusate sodium 50 mg

Purpose

Stool softener


Medication Information

Purpose

Stool softener

Description

Docusate sodium 50 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 42229-5

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week
Section 50569-3

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Section 50570-1

Do not use

  • if you are presently taking mineral oil, unless told to do so by a doctor
Section 53413-1

Questions? 1-888-726-7535

(8am-5pm, EST, Mon.-Fri.).

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over take 1-6 capsules daily
children 2 to under 12 years of age take 1-3 capsules daily
children under 2 years ask a doctor
Active Ingredient

Docusate sodium 50 mg

Inactive Ingredients

D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, PEG 400, propylene glycol, sorbitol

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 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"

  • 1 – 10
  • 2 – 30
  • 3 – 100
  • 4 – 1000
  • 5 – 16000

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 42229-5 (42229-5)

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Section 50570-1 (50570-1)

Do not use

  • if you are presently taking mineral oil, unless told to do so by a doctor
Section 53413-1 (53413-1)

Questions? 1-888-726-7535

(8am-5pm, EST, Mon.-Fri.).

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Stool softener

Directions
  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over take 1-6 capsules daily
children 2 to under 12 years of age take 1-3 capsules daily
children under 2 years ask a doctor
Active Ingredient (Active ingredient)

Docusate sodium 50 mg

Inactive Ingredients (Inactive ingredients)

D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, PEG 400, propylene glycol, sorbitol

Principal Display Panel (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 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"

  • 1 – 10
  • 2 – 30
  • 3 – 100
  • 4 – 1000
  • 5 – 16000

Advanced Ingredient Data


Raw Label Data

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