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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. ADVERSE REACTIONS
    15. PRINCIPAL DISPLAY PANEL

Mineral Oil Product Label

The following document was submitted to the FDA by the labeler of this product Dza Brands 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.

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 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)


Adverse Reactions



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

Disributed by DZA Brands, LLC 2110 Excutive Drive, Salisburg, NC 28147

For product questions or comments contact us at 1-866-322-2439

Please include UPC and code from the package.

831.000/AA


Principal Display Panel



DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

Healthy accents mineral oil USP

Lubricant laxative

relieves occasional constipation

odorless - tasteless - colorless

Compare to Roberts Mineral Oil active ingredient*

16 FL OZ  (1 PT) 473 mL

Made in the USA with US and foreign components

image description - mm1

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831.000/831AA


* Please review the disclaimer below.