MINERAL OIL- mineral oil oil 
Preferred Pharmaceuticals Inc.

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

•
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)

Relabeled By: Preferred Pharmaceuticals Inc.

Mineral Oil
MINERAL OIL 
mineral oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7055(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:68788-7055-4472 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/201807/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/04/201807/24/2020
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7055)

Revised: 7/2020
Document Id: 173291f6-4b8c-4da5-b093-2415f042c64f
Set id: 9024419b-2916-4de2-b743-23b431c46047
Version: 3
Effective Time: 20200724
 
Preferred Pharmaceuticals Inc.