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  5. Label Information: Colace Clear

FDA Label for Colace Clear

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. OTC - QUESTIONS
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colace Clear Product Label

The following document was submitted to the FDA by the labeler of this product Purdue Products Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Colace Clear 50 mg

Active ingredient
(in each soft gel)

Docusate sodium 50 mg


Purpose



Stool softener


Uses



  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Do Not Use



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

Ask A Doctor Before Use If You Have



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

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 stool softener laxative for more than 1 week

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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


Dosage & Administration



Directions: _ Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and overtake 1-6 soft gels daily
children 2 to under 12 years of agetake 1-3 soft gels daily
children under 2 yearsask a doctor

Otc - Questions



Other information

  • each soft gel contains: sodium 3 mg VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
    Keep tightly closed.

Inactive Ingredients



gelatin,glycerin, PEG 400, propylene glycol, sorbitol

Soft gels are imprinted with edible dye-free ink.

©2014, Purdue Products L.P.
Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431
Made in the USA
303458-0A


Package Label.Principal Display Panel



Colace Clear™ 50 mg Carton
NDC: 67818-100-28

Colace Clear 50mg - 303458 0A

Colace Clear 50mg - 303458 0A


* Please review the disclaimer below.