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  5. Label Information: Mineral Oil

FDA Label for Mineral Oil

View Indications, Usage & Precautions

Table of Contents

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

Mineral Oil Product Label

The following document was submitted to the FDA by the labeler of this product Consumer Product Partners, 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.

Disclaimer



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


Active Ingredients



Mineral oil 99.9%


Purpose



Lubricant laxative


Use



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


Warnings



for this product


Do Not Use



  • if you have difficulty swallowing
  • in children under 6 years of age
  • if you are pregnant
  • for a period of 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 wrok.

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 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 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

    children 6 to 12 years of age - 1 to 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 Reaction



Distributed by: Vi-Jon

One Swan Drive

Smyrna, TN 37167


Principal Display Panel



SWAN

MINERAL OIL

U.S.P. LUBRICANT LAXATIVE

  • For Relief of Occasional Constipation
  • Odorless, Tasteless, Colorless

    • COMPARE TO ACTIVE INGREDIENT OF ROBERTS ®MINERAL OIL*

    SEALED WITH PRINTED FOIL CAP FOR YOUR PROTECTION

    16 FL OZ (1 PT) 473 mL

    image description - mm01

    image description - mm01


* Please review the disclaimer below.