Active Ingredient (In Each Capsule)
Docusate sodium (USP) 100 mg
Dulcolax Pink Stool Softener Capsule, Liquid Filled
FDA Label NDC 41167-0281
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Dulcolax Pink Stool Softener (NDC 41167-0281). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, use, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Principal Display Paneldulcolaxpinkstool Softener25 Softgels (Dulcolax Pink Stool Softener 01)
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