FDA Label for Dulcolax Pink Stool Softener

View Indications, Usage & Precautions

Dulcolax Pink 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


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 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

● do not use this product if the safety seal under the cap is torn or missing


Inactive Ingredients



D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, titanium dioxide, water


Questions?



Call 1-866-844-2798 or visit www.Dulcolax.com


Principal Display Panel



Dulcolax
Pink
STOOL SOFTENER
25 SOFTGELS


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