DOCUSATE SODIUM capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)

Available from:

McKesson Packaging Services Business Unit of McKesson Corporation

INN (International Name):

DOCUSATE SODIUM

Composition:

DOCUSATE SODIUM 100 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

unapproved drug other

Summary of Product characteristics

DOCUSATE SODIUM- DOCUSATE SODIUM CAPSULE, LIQUID FILLED
MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
DRUG FACTS
ACTIVE INGREDIENT
Each softgel contains:
Docusate Sodium, 50% w/w in polyethylene glycol 400 (provides 100 mg
Docusate Sodium)
US ES
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
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