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Drug Facts


Stool Softener

Gentle, Effective, Stimulant-Free for Comfortable Relief

Active Ingredient (in Each Capsule)


Docusate sodium 50 mg

Purpose


Stool softener

Uses

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

Warnings


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

Otc - Stop Use Section


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 Section


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

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.

This package is intended for institutional use only.

This package is not child resistant.

Dosage & Administration Section


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

adults and children 12 years and over

take 1-6 capsules daily

children 2 to under 12 years of age

take 1-3 capsules daily

children under 2 years

ask a doctor

Other Information

  • •each capsule 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.
  • •#1 Doctor Recommended Stool-Softener Brand
  • •see window for lot number and expiration date
  • •Questions? 1-888-726-7535 (8am-5pm, EST, Mon.-Fri.).
  • •www.colacecapsules.com

Inactive Ingredients


D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, PEG 400, propylene glycol, sorbitol


Dist. by: Purdue Products L.P. Stamford, CT 06901-3431

Repackaged by: Cardinal Health Zanesville, OH 43701

Principal Display Panel - Carton


NDC: 55154-4709-4

Colace®

(docusate sodium) Capsules

50 mg

60 Capsules

Stool Softener

Gentle, Effective, Stimulant-Free for Comfortable Relief

Dist. by: Purdue Products L.P.

Stamford, CT 06901-3431

Repackaged by: Cardinal Health

Zanesville, OH 43701

LUC4083184-10312

LUC4083184-20312

Pricipal Display Panel - Pouch


Colace®

(docusate sodium) Capsule

50 mg

Principal Display Panel Bag Label


Colace

Docusate Sodium Capsules

50 MG Each

10 Capsules

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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