MINERAL OIL- mineral oil oil 
Geritrex LLC

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.

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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

Ask a doctor before use if you have

Ask a doctor of pharmamcist before use if you are

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

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)

image descriptionimage description

MINERAL OIL 
mineral oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-190
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL471.9528 g  in 472 mL
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-190-16472 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2015
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/FEIBusiness Operations
Geritrex LLC112796248repack(54162-190)
Establishment
NameAddressID/FEIBusiness Operations
Calumet Penreco LLC114222776manufacture(54162-190)

Revised: 7/2015
Document Id: a4e408f8-e32c-4000-aa70-b0c5f0181b42
Set id: 1589ff26-ad82-4520-bd39-f5d5a9c165eb
Version: 1
Effective Time: 20150731
 
Geritrex LLC