HUMCO MINERAL OIL HEAVY- mineral oil liquid

Humco Mineral Oil Heavy by

Drug Labeling and Warnings

Humco Mineral Oil Heavy by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Mineral Oil Heavy

Purpose

Laxative

Use

For relief of occasional constipation or irregularit. Generally produces bowel movement in 6 to 8 hrs.

Warnings

Do not take this product if you have abdominal pain, nausea, vomiting, change in bowel habits persisting more than 2 weeks, rectal bleeding or kidney failure are present, or use for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives.

Do not administer to infants or young children, bedridden or aged patients unless directed by a doctor.

Ask a doctor before use if

you are currently taking a stool softener laxative.

If pregnant or brest feeding ask a health professional before use.

When using this Product discotinue use

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

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.

Directions

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

Children 6 to 12 yrs. of age: 1 to 3 teaspoonfuls at bedtime.

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

Inactive ingredient

dl-alpha-tocopherol as a preservative.

Other information

Keep tightly closed and protect from direct light.

Principal display panel

INGREDIENTS AND APPEARANCE

HUMCO MINERAL OIL HEAVY 
mineral oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-1685
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: 0395-1685-28	3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/25/1998

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(0395-1685) , analysis(0395-1685) , pack(0395-1685) , label(0395-1685)