FDA Label for Oil

View Indications, Usage & Precautions

ACTIVE INGREDIENT
PURPOSE
USE
WARNINGS
ASK A DOCTOR BEFORE USE IF YOU HAVE
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR
IF BREAST-FEEDING
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
OTHER
ALTERNATE PRINCIPAL DISPLAY PANEL - MOUNTAIN FALLS BRAND
PRINCIPAL DISPLAY PANEL

Oil Product Label

The following document was submitted to the FDA by the labeler of this product Vi-jon, 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 mL0 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

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

Distributed by: Vi-Jon

One Swan Drive

Smyrna, TN 37167

Alternate Principal Display Panel - Mountain Falls Brand

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

Mountain falls

Odorless, tasteless and colorless

For relief of occasional constipation

Lubricant laxative

Mineral oil, USP

Made in the USA with US and foreign parts

16 FL OZ (473 mL)

Principal Display Panel

NDC 0869-0831-43

Swan

MINERAL OIL U.S.P. LUBRICANT LAXATIVE

For Relief oc Occasional Constipation

Odorless, Tasteless, Colorless

COMPARE TO ACTIVE INGREDIENT OF ROBERTS MINERAL OIL