MINERAL OIL- mineral oil oil 
Preferred Plus (Kinray)

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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Drug Facts

Active Ingredient

Mineral Oil 100%

Purpose

Lubricant laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 8 hours

Warnings

Do not use

  • in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing
  • if you are presently taking a stool softener laxative
  • for longer than 1 week

Ask a doctor before use if you have

  • abdominal pain, nausea or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

  • do not take with meals
  • take only at bedtime

Stop use and ask a doctor if you have

rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If pregnant or breast feeding,

ask a health professional before use

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control center (1-800-222-1222) right away.

Directions

  • do not take with meals
  • take only at bedtime
  • may be taken as a single daily dose or in divided doses
  • adults and children 12 years of age and over
    • 1 to 3 tablespoons (15 to 45 mL)
    • maximum 3 tablespoons (45 mL) in 24 hours
  • children under 12 years, consult a doctor 

Other Information

  • keep tightly closed
  • protect from direct light

Inactive Ingredient

Vitamin E as stabilizer

Principal Display Panel

Mineral Oil

Lubricant laxative

  • odorless
  • tasteless
  • colorless

FL OZ (mL)

Questions or Comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Kinray LLC.

152-35 Tenth Avenue

Whitestone, NY 11357.

Package Label

Mineral Oil 100%

PREFERRED PLUS PHARMACY Mineral Oil

 

MINERAL OIL 
mineral oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-163
Route of AdministrationORAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL100 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-163-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201512/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33406/30/201512/30/2022
Labeler - Preferred Plus (Kinray) (012574513)

Revised: 11/2020
Document Id: 12865e6b-e224-4560-9840-7feb94fe49ee
Set id: 1eb9cc77-eaeb-495f-a4ca-5cf80ef1aa5b
Version: 3
Effective Time: 20201117
 
Preferred Plus (Kinray)