FDA Label for Stool Softener Docusate Sodium 50 Mg
View Indications, Usage & Precautions
Stool Softener Docusate Sodium 50 Mg Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, 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.
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Drug Facts
Active Ingredient (In Each Softgel)
Docusate Sodium 50 mg
Purpose
Stool softener
Uses
- relieves occasional constipation (irregularity)
- 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
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
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
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 to 6 softgels daily |
Children 2 to under 12 years of age | take 1 to 3 softgels daily |
children under 2 years | ask a doctor |
Other Information
- each softgel contains: sodium 3 mg
VERY LOW SODIUM - store at 15°-30°C (59°-86°F)
Keep tightly closed.
Inactive Ingredients
citric acid, D&C red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink
Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei 430206,
China
Principal Display Panel - 30 Softgel Carotn
STOOL SOFTENER
NDC 69842-072-20
Compare to the active ingredient in Colace® 50 mg
50 MG DOCUSATE SODIUM PER SOFTGEL
Stimulant free
Gentle & effective
Comfortable relief of constipation
30 Softgels
Principal Display Panel - 100 Softgel Carotn
STOOL SOFTENER
NDC 69842-072-24
Compare to the active ingredient in Colace® 50 mg
50 MG DOCUSATE SODIUM PER SOFTGEL
Stimulant free
Gentle & effective
Comfortable relief of constipation
100 Softgels
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