FDA Label for Mineral Oil

View Indications, Usage & Precautions

Mineral Oil Product Label

The following document was submitted to the FDA by the labeler of this product Amazon.com Services 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 productes bowel movement in 6 to 8 hours.


Warnings



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 signd 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)


Other



DISTRIBUTED BY:

Amazon.com, Services, Inc

Seattle, WA 98109

1-877-485-0385

2018 Amazon.com, Inc. or its afiliated.

All rights reserved. Solimo and all related logos are are trademarks of

Amazon.com, Inc or its affiliates.

831.000/831AA


Principal Display Panel



SOLIMO

MINERAL OIL U.S.P.

LUBRICANT LAXATIVE

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION.

16 FL OZ (1 PT) 473 mL


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