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Mineral oil by P & L Development, LLC

Medically reviewed on October 21, 2016

Dosage form: oil
Ingredients: MINERAL OIL 100mg in 100mL
Labeler: P & L Development, LLC
NDC Code: 49580-0334

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.

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 women, 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 ingestion, 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 ingredients

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.

Manufactured by:

PL Developments

1874 Hwy 72 W,

Clinton, SC 29325

Package Label

ReadyinCase Mineral Oil

MINERAL OIL 
mineral oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0334
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL100 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL 
Packaging
#Item CodePackage Description
1NDC:49580-0334-6473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33408/31/2014
Labeler - P & L Development, LLC (101896231)

 
P & L Development, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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