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Mineral Oil by TopCo Associates

Medically reviewed on December 21, 2017

Dosage form: liquid
Ingredients: MINERAL OIL 999mg in 1mL
Labeler: TopCo Associates
NDC Code: 36800-931

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.

Mineral Oil

Active ingredient

Mineral oil 99.9%


Lubricant laxative


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.

  • 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)



Dist. By. topco Assoc. LLC, 150 Northwest Point Blvd., Elk Grove Villiage, IL 60007

(c) Topco Questions? 1-888-423-0139

Made in the US with US and foreign components

Principal Display Panel

Mineral oil usp

lubricant laxative

for relief of occasional constipation

  • odorless
  • tasteless
  • colorless


16 FL OZ (1 PT) 473 mL


mineral oil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-931
Route of AdministrationORAL, TOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage Description
1NDC:36800-931-43473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/22/2004
Labeler - TopCo Associates (006935977)
Registrant - Vi-Jon (790752542)

TopCo Associates

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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.