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STOOL SOFTENER (docusate sodium 100 mg) Dailymed

  1. Human OTC
  2. Archived
  3. Care One (American Sales Company)

Generic: docusate sodium

STOOL SOFTENER capsule, liquid filled - (docusate sodium 100 mg) image
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IMPRINT: P10 51A     SHAPE: oval

All Imprints

docusate sodium 100 mg - p10 51a oval

docusate sodium 100 mg oral capsule - p10 51a oval red

docusate sodium 100 mg oral capsule - p10 51a oval

  1. FDA Adverse Reactions

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Active Ingredient (in Each Capsule)


Docusate Sodium 100 mg

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 by a doctor
  • when abdominal pain, nausea or vomiting are present
  • for longer than one 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 rectal bleeding
  • you fail to have a bowel movement after use

If pregnant or breast-feeding,


ask a health care 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

  • adults and children 12 years and over: take 1- 2 capsules preferably at bedtime
  • children 6 to 12 years of age: take 1 capsule at bedtime

Other Information

  • each capsule contains: sodium 6 mg
  • store at controlled room temperature 15o - 30o C (59o- 86o F)
  • do not use if imprinted safety seal under cap is broken or missing.
  • *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®

Inactive Ingredients


D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and titanium dioxide. May also contain: FD&C blue #1 and purified water.

Principal Display Panel


Compare to active ingredient of COLACE®*

stool softener

Docusate sodium 100 mg

Distributed by: American Sales Company

4201 walden avenue, Lancaster, NY 14086

Product Label

Docusate Sodium 100 mg

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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