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  5. Label Information: Extra Strength Stool Softener Laxative

FDA Label for Extra Strength Stool Softener Laxative

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES
    4. WARNINGS - DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREASTFEEDING
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRODUCT LABELING
    14. PACKAGE LABEL

Extra Strength Stool Softener Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Dispensing Solutions, 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.

Active Ingredient (In Each Softgel)



Docusate Sodium 250mg


Purpose



Stool softener


Uses



  • Relieves occasional constipation.
  • Generally produces bowel movement within 12 to72 hours.

Warnings - Do Not Use



  • for longer than one week
  • if you are taking mineral oil
  • when abdominal pain, nausea, or vomiting are present

Ask A Doctor Before Use If



you have a sudden change in bowel habits that lasts over two 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 experience rectal bleeding
  • you fail to have a bowel movement after using this product

    • These may indicate a serious condition.


If Pregnant Or Breastfeeding



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.


Directions



  • adults and children over 12 years and over:1 capsule once daily
  • children under 12 years: ask a doctor

Other Information



  • store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)

    • Each capsule contains sodium 15mg


Inactive Ingredients



edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.


Questions Or Comments?



Call 1-800-645-2158, 9am - 5am ET Monday - Friday


Product Labeling



Rugby Extra Strength Stool Softener Laxative
Docusate Sodium USP, 250mg

Mfd for: Rugby Laboratories, Inc
Duluth Georgia 30097
www.rugbylaboratories.com


Package Label



NDC 66336-0010-XX


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