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  5. Label Information: Mineral Oil

FDA Label for Mineral Oil

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR
    9. IF BREAST FEEDING
    10. KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. DISCLAIMER
    15. ADVERSE REACTIONS
    16. PRINCIPAL DISPLAY PANEL

Mineral Oil Product Label

The following document was submitted to the FDA by the labeler of this product Perrigo Direct, 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



Mineral oil 99.9%


Purpose



Lubricant laxative


Use



for relief of occasional constipation (irregularity).  Generally produces bowel movement in 6 to 8 hours


Do Not Use



  • if you have difficulty swallowing
  • in children under 6 years of age
  • if you are pregnant
  • for a period longer than 1 week
  • if you are bedridden or aged

Ask A Doctor Before Use If You Have



  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are



  • presently taking a stool softener laxative
  • taking any other drug.  Take this product 2 or more hours before or after other drugs.  Laxatives may affect how other drugs work

When Using This Product



do not take with meals.  Take only at bedtime.


Stop Use And Ask A Doctor



if you have rectal bleeding or failure to have a bowel movement after use.  These could be signs of a serious condition.


If 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


Directions



  • do not take with meals
  • take only at bedtime
  • may be taken as a single daily dose or in divided doses

    • adults and children 12 years of age and over - 1 to 3 Tablespoons (15 - 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

    children 6 to under 12 years of age - 1 to 3 teaspoons (5 - 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

    children under 6 years of age - do not use, consult a doctor


Other Information



keep tightly closed.  Protect from sunlight


Inactive Ingredients



mixed tocopherols (added as a stabilizer)


Disclaimer



This product is not manufactured or distributed by Roberts Pharmaceutical Corp., distibutor of Roberts Mineral Oil


Adverse Reactions



Distributed By: Geiss, Destin & Dunn, Inc

Peachtree City, GA 30269

www.valuelabels.com

831.000/831AA


Principal Display Panel



NDC 50804-831-43

GoodSense

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

Mineral Oil USP

Lubricant Laxative

For relief of occasional constipatio

ODORLESS - TASTELESS - COLORLESS

100%

SATISFACTION

GUARANTEED

Compare to active ingredient of

Roberts Mineral Oil

16 FL OZ (1 PT) 473 mL

Made in the USA with US and foreign components

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* Please review the disclaimer below.