DOCUSATE SODIUM description, usages, side effects, indications, overdosage, supplying and lots more!

DOCUSATE SODIUM

LLC Federal Solutions

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert



FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Active ingredient per 5 mL (1 teaspoon)
Docusate Sodium 50 mg

Purpose

Purpose
Stool Softener Laxative

Uses

Use

  • For relief of  occasional constipation
  • generally produces bowel movement in 12-72 hours

Warnings

Do not use

  • if you are presently taking mineral oil
  • when abdominal pain, nausea, or vomiting are present
  • for longer than one week

Ask a doctor before use if you have
noticed a sudden change in bowel habits that lasts over two weeks.

Ask a doctor or pharmacist before use if you are
taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product

These may indicate a serious condition.

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

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

Directions

  • may be taken once daily or in divided doses
  • give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation

adults and children over 12                         5 to 35 mL (1 to 7 teaspoons)
children 6 to under 12                                5 to 15 mL (1 to 3 teaspoons)
children 2 to under 6                                  2.5 to 5 mL (1/2 to 1 teaspoon)
children under 2                                         ask a doctor

Other information

  • each teaspoon contains: sodium 5 mg
  • shake well before using
  • store at controlled room temperature 15° - 30°C (59° - 86°F)
  • dispense contents in a tight, light resistant container as defined in the USP.

Inactive ingredients
D&C Red #33, methylparaben, natural & artificial vanilla flavor, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH.

Questions or comments?

  • Call 1-855-333-6337
  • To Report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

Repackaged by:
Safecor Health, LLC
317 New Boston St.
Woburn, MA 01801
Distributed by: LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33132

REV 105-00          07/2013



———PRINCIPAL DISPLAY PANEL———
NDC: 24451-771-25
DOCUSATE SODIUM
250 mg / 25 mL
(DOCU LIQUID)
DELIVERS 25 mL

SHAKE WELL BEFORE USING
Exp: 00/00/00 Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132

DOCUSATE SODIUM

DOCUSATE SODIUM LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:24451-771(NDC:50383-771)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 50 mg

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 33
METHYLPARABEN
POLOXAMER 181
POLYETHYLENE GLYCOLS
propylene glycol
PROPYLPARABEN
water
SODIUM BENZOATE
SODIUM CITRATE

Product Characteristics

Color
pink

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 25 in 1 CUP, UNIT-DOSE
2 NDC:24451-771-25 100 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2013-08-08


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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