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  5. Label Information: Stool Softener And Laxative

FDA Label for Stool Softener And Laxative

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
    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 And Laxative 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 50 mg

Sennosides 8.6 mg


Purpose



Stool softener

Laxative


Uses



• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours


Warnings



• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours


Do Not Use



• if you are now taking mineral oil, unless directed by a doctor • laxative products for longer than 1 week, unless directed by a doctor


Ask A Doctor Before Use If You Have



• stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that continues over a period of 2 weeks


Ask A Doctor Or Pharmacist Before Use



if you are if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.


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 preferably at bedtime or as directed by a doctor

AgeStarting DosageMaximum Dosage
adults & children 12 years of age & over2 tablets once a day4 tablets twice a day
children 6 to under 12 years of age1 tablet once a day2 tablets twice a day
children 2 to under 6 years½ tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor


Other Information



• each tablet contains: calcium 20 mg and sodium 6 mg
• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F)


Inactive Ingredients



Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow No. 10, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, maltodextrin, polyethylene glycol 400, purified water, sodium benzoate, stearic acid, titanium dioxide


Questions Or Comments?



1-888-333-9792


Distributed By:



Cabinet Health P.B.C.


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