FDA Label for Dulcolax Stool Softener
View Indications, Usage & Precautions
Dulcolax Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product Chattem, Inc.. 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.
Active Ingredient (In Each Capsule)
Docusate sodium (USP) 100 mg
Purpose
Stool softener laxative
Use
● for relief of occasional constipation and irregularity
● this product 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 or vomiting
● a sudden change in bowel habits that lasts more than 2 weeks
Stop Use And Ask A Doctor If
● you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
● you need to use a laxative for more than 1 week
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
take with a glass of water
adults and children 12 years of age and over 1 to 3 capsules daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of age 1 capsule daily
children under 2 years of age ask a doctor
Other Information
● each capsule contains: sodium 6 mg
● store at 20°-25°C (68°-77°F). Protect from excessive humidity
● contains FD&C Yellow No. 6
● do not use this product if the safety seal under the cap is torn or missing
Inactive Ingredients
FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, water
Questions?
Call 1-866-844-2798 or visit www.Dulcolax.com
Keep carton as it contains important product information.
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Dulcolax
Stool Softener
25 Liquid Gels
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