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  5. Label Information: Phillips Stool Softener Bulk Docusate

FDA Label for Phillips Stool Softener Bulk Docusate

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    3. PURPOSE
    4. USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - ASK DOCTOR/PHARMACIST
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 30 CAPSULE CARTON

Phillips Stool Softener Bulk Docusate Product Label

The following document was submitted to the FDA by the labeler of this product Bayer Healthcare 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.

Other



Drug Facts


Active Ingredient (In Each Softgel)



Docusate sodium 100 mg


Purpose



Stool softener laxative


Use



  • for relief of occasional constipation (irregularity)
  • this product generally produces a bowel movement in 12 to 72 hours

Ask A Doctor Before Use If You Have



  • stomach pain, nausea, or vomiting
  • a sudden change in bowel habits that lasts over 14 days

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are presently taking mineral oil


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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • take softgels with a full glass (8 oz) of water
    • adults and children 12 years and oldertake 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
    children 6 to under 12 yearstake 1 softgel daily or as directed by a doctor
    children under 6 years of ageask a doctor

Other Information



  • each softgel contains: sodium 6 mg
  • very low sodium
  • store at room temperature. Avoid excessive heat 40°C (104°F).

Inactive Ingredients



FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide


Questions Or Comments?



1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.bayercare.com


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