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

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Docusate Sodium

A&Z Pharmaceutical, Inc.
A&Z Pharmaceutical, Inc.

Docusate Sodium capsule, liquid filled


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS (IN EACH CAPSULE)

Docusate Sodium 100mg

PURPOSE

Stool softener

USES

(for the prevention of dry, hard stools (for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

WARNINGS

Do Not Use

(if you are currently taking mineral oil, unless directed to do so by a doctor (when abdominal pain, nausea, or vomiting are present (for longer than 1 week unless directed by a doctor

Ask a Doctor before use if you

Notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop Use and ask a doctor if you

(have a rectal bleeding (fail to have a bowel movement occur after use (You may report side effects to 1-888-952-0050

If pregnant or breast-feeding,

Ask a health professional before use.

Keep Out of Reach of Children

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

DIRECTIONS

(Adults and children 12 years and over: take 1-3 capsules, preferably at bedtime

(Children 2 to under 12 years of age: take 1 capsule at bedtime

(Children under 2 years of age: ask a doctor

OTHER INFORMATION

(each capsule contains: sodium 5mg (store at room temperature 15-30°C (59-86°F)

INACTIVE INGREDIENTS

FD&C red # 40, gelatin, glycerin, polyethylene glycol, propylene glycol, and sorbitol special. May also contain: D&C yellow #10, FD&C yellow #6 and purified water.

PRINCIPAL DISPLAY PANEL

Docusate Sodium

Docusate Sodium CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62211-314
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
FD&C RED NO. 40
GELATIN
GLYCERIN
propylene glycol
sorbitol
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
water
POLYETHYLENE GLYCOLS

Product Characteristics

Color Size Imprint Code Shape
red (clear) 5 mm none OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62211-314-30 30 in 1 BOTTLE
2 NDC:62211-314-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-09-15


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