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Mineral Oil by Geritrex LLC

Medically reviewed on July 31, 2017

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%

Purpose:

Lubricant Laxative

Uses

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 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

Directions
  • 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

Geritrex

Mineral Oil

USP

Lubricant Laxative

Odorless

Tasteless

Colorless

16 OZ (472 ml)

MINERAL OIL 
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
MINERAL OIL (MINERAL OIL) MINERAL OIL471.9528 g  in 472 mL
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL 
Packaging
#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)
Establishment
NameAddressID/FEIOperations
Geritrex LLC112796248repack(54162-190)
Establishment
NameAddressID/FEIOperations
Calumet Penreco LLC114222776manufacture(54162-190)

 
Geritrex LLC

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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.

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