Mineral Oil by DZA Brands LLC / Vi-Jon MINERAL OIL liquid

Mineral Oil by

Drug Labeling and Warnings

Mineral Oil by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 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)

Adverse Reactions

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

Disributed by DZA Brands, LLC 2110 Excutive Drive, Salisburg, NC 28147

For product questions or comments contact us at 1-866-322-2439

Please include UPC and code from the package.

831.000/AA

principal display panel

DO NOTE USE IF PRINTED SEAL UNDER  CAP IS BROKEN OR MISSING

healthy

accents

mineral oil

USP

lubricant

laxative

relieves occasional constipation

• odorless
• tasteless
• colorless

compare to Roberts

Mineral Oil

active ingredients

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-831
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	999 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-831-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/22/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/22/2007

Labeler - DZA Brands LLC (090322194)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55316-831)