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  5. Label Information: Stool Softener Regular Strength

FDA Label for Stool Softener Regular Strength

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE IF YOU HAVE
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. DISTRIBUTED BY:
    17. POUCH

Stool Softener Regular Strength Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals 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.

Drug Facts




Active Ingredient (In Each Tablet)



Docusate sodium 100 mg


Purpose



Stool softener


Uses



• relieves occasional constipation (irregularity) • generally produces bowel movement in 12–72 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



• fever • mucus in the stool


Ask A Doctor Or Pharmacist Before Use If You Are 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


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 asingle daily dose or in divided doses.

adults & children 12 years of age & overtake 1–3 softgels daily
children 2 to under 12 years of agetake 1 softgel daily
children under 2 years of ageask a doctor


Other Information



• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F) • Keep tightly closed


Inactive Ingredients



FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution


Questions Or Comments?



1-888-333-9792


Distributed By:



Cabinet Health P.B.C.


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