LEADER MINERAL OIL- mineral oil liquid

LEADER Mineral Oil by

Drug Labeling and Warnings

LEADER Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba Leader, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Mineral Oil

PURPOSE

Lubricant Laxative

INDICATIONS & USAGE

For relief of occasional constpation or irregularity. Generally produces bowel movement in 6 to 8 hours.

WARNINGS

Do not use if you have difficulty swallowing, in children under 12 years of age, if you are pregnant, for a period longer than 1 week, if you are bedridden or aged, if you are presently taking a stool softener laxative

ASK DOCTOR

Ask a doctor before usage if you hav abdominal pain, nausea, or vomiting, noticed a sudden change in bowel habits that persists over a period of 2 weeks.

KEEP OUT OF REACH OF CHILDREN

In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.

STOP USE

and consult a doctor if there is a fialure to have a bowel movement after use.

DOSAGE & ADMINISTRATION

Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime.

Children 6 to 12 yes of age: 1 to 3 teaspoonfulls at bedtime.

Children under 6 yrs of age: Consult a doctor before use

INACTIVE INGREDIENT

dl-alpha-tocopherol as a preservative

OTHER SAFETY INFORMATION

Keep tightly closed and protected from direct light

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER MINERAL OIL 
mineral oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0448
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	1000 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0448-1	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	12/18/2018

Labeler - Cardinal Health (097537435)

Registrant - Humco Holding Group, Inc (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc		825672884	analysis(70000-0448) , manufacture(70000-0448) , pack(70000-0448) , label(70000-0448)