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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. QUESTIONS
    15. OTHER
    16. PRINCIPAL DISPLAY PANEL

Mineral Oil Product Label

The following document was submitted to the FDA by the labeler of this product Retail Business Services. 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 othr 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)


Questions



Questions? Call 1-877-846-9949


Other



DISTRIBUTED BY: FOODHOLD U.S.A., LLC, LANDOVER, MD 20785

For product questions or concerns, contact us at 1-877-846-9949

2018 Ahold Delhaize Licensing Sari Quality guaranteed or your money back.


Principal Display Panel



CAREONE

MINERAL OIL

USP

Lubricant Laxative

For relief of occaskonal contipation

ODORLESS - TASTELESS - COLORLESS

MADE IN THE USE WITH US AND FOREIGN COMPONENTS

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

OUR PHARMACISTS RECOMMEND

16 FL OZ (1 PT) 473 mL

image description - mm3

image description - mm3


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