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Mineral Oil by Geritrex LLC

Dosage form: oil
Ingredients: MINERAL OIL 471.9528g in 472mL
Labeler: Geritrex LLC
NDC Code: 54162-190

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 99.99%


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 one 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 of pharmamcist 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 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 pregnant or breast feeding,

ask a health professional before use.

Keep out of the reach of children

In case of accidental 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

Age                                                      Dose

adults and children over 12 years         1 to 3 tablespoons (15 to 45 ml)

                                                          maximum 3 tablespoons (45mL) in 24 hours

children 6 years to under 12 years         1 to 3 teaspoons(15 to 45 ml)

                                                          maximum 3 teaspoons (45mL) in 24 hours

Children under 6 years                           Do not use, consult a doctor

Other Information

Keep tightly closed. Protect from sunlight. For more info call 800-736-3437

Inactive Ingredients

Mixed tocopherols (added as a stabilizer)

Principal Display Panel


Mineral Oil


Lubricant Laxative




16 OZ (472 ml)

mineral oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-190
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage Description
1NDC:54162-190-16472 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/31/2015
Labeler - Geritrex LLC (112796248)
Registrant - Geritrex LLC (112796248)
Geritrex LLC112796248repack(54162-190)
Calumet Penreco LLC114222776manufacture(54162-190)

Geritrex LLC

← See all Mineral Oil brands

Medically reviewed on Jul 31, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.