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:                          Purpose: Mineral Oil USP 100%......................Lubricant Laxative

Uses: For relief of fecal impaction or occasional constipation, without straining or irritating the mucosa of the bowel, by lubricating and softening the stool. Generally produces bowel movement in 2 to 15 minutes. Professional Use: For cleansing the bowel and removal of residue after barium enema administration

INDICATIONS & USAGE

WARNINGS

Dosage wanring: Using more than one enema in 24 hours can be harmful

​Caution: For rectal use only

Ask a doctor before using laxative if you:

• Have nausea, vomiting, or abdominal pain
• Have suddent change in bowel habits lasting more than two weeks
• Have already used a laxative for more than 1 week

​Ask a doctor of pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

​When using this product, do not use more than directed.

Serious side effects may occur from excess dosage.

​Stop using this product and consult a doctor if you:

• Have rectal bleeding
• Have no bowel movemenet after the enema is given

These symptoms may indicated a serious condition.

PREGNANCY OR BREAST FEEDING

​If pregnant or breastfeeding​ ​ ​Ask a health professional before use.

INACTIVE INGREDIENT

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN
In the case of accidental ingestion contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Remove orange protective shield before inserting by holding bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove, then insert lubricated tip into rectum and squeeze gently.

STORAGE AND HANDLING

Store at room temperature 59°-86°F (15°-30°C)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-175
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	100 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
VITAMIN D (UNII: 9VU1KI44GP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-175-05	113 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	07/31/2015
2	NDC: 54162-175-12	113 g in 1 BOTTLE, WITH APPLICATOR; 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(54162-175)

Establishment
Name	Address	ID/FEI	Business Operations
Calumet Penreco LLC		114222776	manufacture(54162-175)