Mineral Oil by Geritrex LLC / Calumet Penreco LLC MINERAL OIL oil

Mineral Oil by

Drug Labeling and Warnings

Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Geritrex LLC, Calumet Penreco LLC. 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)

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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: 54162-190-16	472 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/31/2015

Labeler - Geritrex LLC (112796248)

Registrant - Geritrex LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex LLC		112796248	repack(54162-190)

Establishment
Name	Address	ID/FEI	Business Operations
Calumet Penreco LLC		114222776	manufacture(54162-190)