FDA Label for Mineral Oil
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USE
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AD ASK A DOCTOR
- IF BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- OTHER
- PRINCIPAL DISPLAY PANEL
Mineral Oil Product Label
The following document was submitted to the FDA by the labeler of this product Shopko Stores Operating Co., 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
- if you are pregnant
- if you are bedridden or aged
- in children under 6 years of age
- for a period longer than 1 week
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 Ad Ask A Doctor
if you have rectal bleeding or failure to have a bowel movement after use. The coudlbe 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 takw 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 ad 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)
Other
Made in the USA with US and foreign components
Manufactured by Vi-Jon, Inc
One Swan Drive, Smyrna, TN 37167
for ShopKo Stores Operating Co. LLC
Principal Display Panel
ShopKo Mineral Oil U.S.P.
Lubricant Laxative
For Relief or Occasional Constipation
- Odorless
- Tastless
- Colorless
Sealed with printed foil under cap for your protection
16 FL OZ (1 PT) 473 mL
831.000/831AA
* Please review the disclaimer below.