MINERAL OIL HEAVY- mineral oil liquid

Mineral Oil Heavy by

Drug Labeling and Warnings

Mineral Oil Heavy by is a Otc medication manufactured, distributed, or labeled by 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.

CVS Label

Leader Label

INGREDIENTS AND APPEARANCE

MINERAL OIL HEAVY 
mineral oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82645-906
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: 82645-906-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/18/2018
2	NDC: 82645-906-32	950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	12/18/2018

Labeler - Pharma Nobis, LLC (118564114)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(82645-906) , analysis(82645-906) , pack(82645-906) , label(82645-906)