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  5. Label Information: Basic Care Stool Softener

FDA Label for Basic Care Stool Softener

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL

Basic Care Stool Softener Product Label

The following document was submitted to the FDA by the labeler of this product Amazon.com Services Llc. 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 Softgel)



Docusate sodium 100 mg


Purpose



Stool softener laxative


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

Ask A Doctor Or Pharmacist Before Use If You Are



taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.


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 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 (1-800-222-1222).


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 - 3 softgels daily

    children 2 to under 12 years of age

    take 1 softgel daily

    children under 2 years

    ask a doctor


Other Information



  • •each softgel contains: sodium 6 mg
  • •very low sodium
  • •store at 20-25°C (68-77°F)

Inactive Ingredients



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


Questions?



1-800-719-9260


Principal Display Panel



Softgels

Compare to Colace® active ingredient

Stool Softener

Docusate Sodium 100 mg

Stool Softener

actual size

Laxative

Gentle

Dependable Effect

Stimulant-Free

100 SOFTGELS

486-bn-stool-softener - image 01

486-bn-stool-softener - image 01


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