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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Private Label Mineral Oil 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.

CVS Label

CVS Mineral Oil 32 oz Back.jpgCVS Mineral Oil 32 oz Front.jpg

Leader Label

LDRMinH.jpg

MINERAL OIL HEAVY 
mineral oil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9135
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:0395-9135-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/18/2018
2NDC:0395-9135-32950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/18/2018
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc.825672884manufacture(0395-9135) , analysis(0395-9135) , pack(0395-9135) , label(0395-9135)

Revised: 6/2020
Document Id: a8c1f436-e5de-0cc0-e053-2a95a90a2d16
Set id: a8c1f436-e5dd-0cc0-e053-2a95a90a2d16
Version: 1
Effective Time: 20200623
 
Humco Holding Group, Inc.