Skip to Content

← See all Mineral Oil brands

Mineral Oil by Cardinal Health

Medically reviewed on November 15, 2017

Dosage form: liquid
Ingredients: MINERAL OIL 1mL in 100L
Labeler: Cardinal Health
NDC Code: 37205-831

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

Active ingredient
Mineral oil 99.99%

Purpose
Lubricant laxative

Use for relief of occasional constipation(irregularity).  Generally
produces 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 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 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 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours
children 6 to under 12 years of age - 1 to 3 teaspoons (5 to 15 mL) maximum 3 teaspoons (15mL) 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)

Distributed by Cardinal Health, Dublin, Ohio 43017
www.myleader.com  1-800-260-6313

NDC 37205-831-43
LEADER
Compare to Roberts
active ingredients
MINERAL
OIL
U.S.P.
Lubricant Laxative
For Relief of Occasional Constipation
Odorless • Tasteless • Colorless
SEALED WITH PRINTED FOIL
UNDER CAP FOR YOUR PROTECTION
16 FL OZ (1pt) 473 mL)
MINERAL OIL 
mineral oil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-831
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL ) MINERAL OIL 1 mL  in 100 L
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL 
Packaging
#Item CodePackage Description
1NDC:37205-831-43.473 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/21/1989
Labeler - Cardinal Health (097537435)
Registrant - Vi-Jon, Inc (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon, Inc790752542manufacture

 
Cardinal Health

← See all Mineral Oil brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide