HUMCO MINERAL OIL HEAVY- mineral oil liquid 
Humco Holding Group, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Humco Mineral Oil USP Heavy

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.

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HUMCO MINERAL OIL HEAVY 
mineral oil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-1685
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL1000 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-1685-283800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/25/1998
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(0395-1685) , analysis(0395-1685) , pack(0395-1685) , label(0395-1685)

Revised: 3/2022
Document Id: da6bf9ac-24b9-2f39-e053-2a95a90afa82
Set id: 9f943fdf-5058-4e18-ba96-6be112bf72ca
Version: 4
Effective Time: 20220317
 
Humco Holding Group, Inc.