Mineral Oil by Preferred Pharmaceuticals Inc. MINERAL OIL oil

Mineral Oil by

Drug Labeling and Warnings

Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-7055(NDC:54162-190)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	471.9528 g  in 472 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-7055-4	472 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/04/2018

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-7055)