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  5. Label Information: Leader Ready To Use Mineral Oil Laxative

FDA Label for Leader Ready To Use Mineral Oil Laxative

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 118 ML DELIVERED DOSE)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE
    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 - 133 ML BOTTLE CARTON

Leader Ready To Use Mineral Oil 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.

Other



Drug Facts

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017


Active Ingredient (In Each 118 Ml Delivered Dose)



Mineral oil 100%


Purpose



Lubricant laxative


Uses



  • for relief of occasional constipation
  • for relief of fecal impaction
  • for removal of residue after barium administration

Warnings



For rectal use only


Ask A Doctor Before Use



  • if you have abdominal pain, nausea, or vomiting
  • if you have a sudden change in bowel habits that persists over a period of 2 weeks
  • if you have already used a laxative for more than 1 week
  • if constipation continues after one week of use, contact your doctor

Stop Use And Ask A Doctor If



  • you have rectal bleeding or no bowel movement within 15 minutes of using this product
  • you need to use a laxative for more than one week

    • These symptoms may indicate a serious condition.


Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions



Single daily dose (per 24 hours).

adults & children 12 years and over1 bottle once daily
children 2 to under 12 years1/2 bottle once daily discard unused portion
children under 2 yearsDO NOT USE

Other Information



  • store at 15°-30°C (59°-86°F)
  • this product generally produces a bowel movement in 2 to 15 minutes

Inactive Ingredients



none


Questions Or Comments?



1-866-323-0107


Principal Display Panel - 133 Ml Bottle Carton



LEADER™

NDC 70000-0109-1

Ready-To-Use
Enema
Mineral Oil
Lubricant Laxative

Sodium Free

For Relief Of:

Occasional
Constipation

Comfortable,
Lubricated Tip

Works in
Minutes

Not Made
With Natural
Rubber
Latex

COMPARE TO
FLEET® MINERAL
OIL ENEMA
active ingredient*

1 BOTTLE

100% Money
Back Guarantee

4 .5 FL OZ (133 mL)

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton - leader 01

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton - leader 01


* Please review the disclaimer below.