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  5. Label Information: Leader Stool Softener Plus Stimulant Laxative

FDA Label for Leader Stool Softener Plus Stimulant Laxative

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS - DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    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. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    14. PRODUCT LABELING

Leader Stool Softener Plus Stimulant Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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 Ingredients (In Each Tablet)



Docusate Sodium 50mg
Sennosides 8.6mg


Purpose



Stool softener
Stimulant Laxative


Uses



  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement within 6 to 12hours.

Warnings - Do Not Use



  • laxative products for longer than 1 week unless told to do so by a doctor.
  • 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.

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

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 immediately.


Directions



Take only by mouth. Doses may be taken as a single daily does or in divided doses.

  • adults and children 12 years and over: take 2-4 tablets daily
  • children 6 to under 12 years of age: take 1-2 tablets daily
  • children 2 to under 6 years of age: take up to 1 tablet daily
  • children under 2: ask a doctor

Other Information



  • each softgel contains: sodium 6mg VERY LOW SODIUM
  • each tablet contains: calcium 20mg/tablets
  • store at 15 - 30 degrees C (59-86 degrees F), protect from excessive moisture
  • do not use if imprinted safety seal under cap is broken or missing.
  • *This product is not manufactured or distributed by Purdue Products, LP, owner of the registered trademark Peri Colace.

Inactive Ingredients



carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethanol, FDandC Blue no2 Aluminum Lake, FDandC Red No40 Aluminum Lake, hypromellose, magnesium stearate, *maltodextrin, microcrystalline cellulose, *mineral oil, *Opadry II red, polyethylene glycol (PEG) 400, *pregelatinized starch, *silicon dioxide 50s, sodium benzoate, stearic acid and titanium dioxide. *May also contain.


Questions Or Comments?



call toll free:1-800-200-6313


Package Label.Principal Display Panel



Comapre to the active ingredient Peri Colace               

Leader

Stool Softener plus Stimulant Laxative

Docusate Sodium 50mg
Sennosides, 8.6mg

Relieves of Occasional Constipation
100 Softgels

Distributed by Cardinal Health
Dublin, Ohio 43017
CIN 1382639

www.myleader.com
1-800-200-6313

All Leader Brand Products are 100% satisfaction guaranteed or return to place of purchase for a full refund.


Product Labeling



Stool Softener - ssandlaxative

Stool Softener - ssandlaxative


* Please review the disclaimer below.