Docusate Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

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Docusate Sodium

McKesson Packaging Services Business Unit of McKesson Corporation

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Each softgel contains:
Docusate Sodium, 50% w/w in polyethylene glycol 400 (provides 100 mg Docusate Sodium)

Docusate Sodium Uses

Temporary relief of occasional constipation. This product generally produces a bowel movement in 12 to 72 hours.

Warnings

Do not use:

If abdominal pain, nausea or vomiting are present.

Ask a doctor before use if:

You have noticed a sudden change in bowel habits that persist over a period of 2 weeks. You are presently taking mineral oil. Stop use and ask a doctor if: Rectal bleeding or failure to have a bowel movement occur after use, which may indicate a serious condition. You need to use a laxative for more than 1 week.

If you are pregnant or breast-feeding:

Ask a health professional before use.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age and over. Take 1 to 3 softgels daily.

Children 2 to under 12 years. Take 1 softgel daily.

Children under 2 years ask a doctor.

Other Information

Each softgel contains: Sodium, 5mg

Store at 15°-30°C (59°-86°F). Protect from excessive moisture.

Inactive ingredients

Gelatin, Polyethylene Glycol 400, Sorbitol Special™ (Sorbitol, sorbitol anhydrides, purified water and mannitol), Glycerin, Purified Water, Propylene Glycol, FD&C Red #40, FD&C Yellow #6, Edible white printing ink.

PACKAGE DISPLAY PANEL

Docusate Sodium

ADDITIONAL LABEL TEXT

NDC 63739-089-01

DOCUSATE SODIUM
100 mg Sofgels™

STOOL SOFTENER

UD 750 Softgels (25X30)

Mfg. By: Banner Pharmacaps® High Point, NC USA 27265

Dist. By: McKesson Packaging Concord, NC 28027

FOR INSTITUTIONAL USE ONLY.
See window at back of box for expiration date and lot number.

LS-089-01-M07-01-A-R1

PACKAGE DISPLAY PANEL

Docusate Sodium

ADDITIONAL LABEL TEXT

NDC 63739-089-03

DOCUSATE SODIUM
100 mg Sofgels™

STOOL SOFTENER

PC 750 Softgels (25X30)

Mfg. By: Banner Pharmacaps® High Point, NC USA 27265

Dist. By: McKesson Packaging Concord, NC 28027

FOR INSTITUTIONAL USE ONLY.
See window at back of box for expiration date and lot number.

PACKAGE DISPLAY PANEL

Docusate Sodium

ADDITIONAL LABEL TEXT

NDC 63739-089-10

DOCUSATE SODIUM
100 mg Sofgels™

STOOL SOFTENER

UD 100 Softgels (10x10)

For Directions and Other Warnings:
See accompanying Patient Insert.
Consult a physician before the use of this product.

Mfg. By: Banner Pharmacaps® High Point, NC USA 27265

Docusate Sodium

Docusate Sodium CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63739-089
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 100 mg

Inactive Ingredients

Ingredient Name Strength
polyethylene glycol 400
sorbitol
water
mannitol
GLYCERIN
propylene glycol
FD&C RED NO. 40
FD&C YELLOW NO. 6

Product Characteristics

Color Size Imprint Code Shape
ORANGE (Orange/Red translucent) 13 mm P51 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BLISTER PACK
2 30 in 1 BLISTER PACK
3 10 in 1 BLISTER PACK
4 NDC:63739-089-10 10 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2004-12-01


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Be sure to consult your doctor before taking any medication!
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