Your browser does not support JavaScript! MINERAL OIL LIQUID [DOLGENCORP, LLC]
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RxNorm Names

MINERAL OIL liquid
[DOLGENCORP, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active ingredient

Mineral oil 99.9%

Purpose

Lubricant laxative

Use

for relief of occasional constipation (irregularity).  Generally produces bowel movement in 6 to 8 hours

Do not use

  • if you have difficulty swallowing
  • in children under 6 years of age
  • if you are pregnant
  • for a period longer than week
  • if you are bedridden or aged

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

Ask a doctor or pharmacist before use if you are

  • presently taking a stool softener laxative
  • taking any other drug.  Take this product 2 or more hours before or after other drugs.  Laxatives may affect how other drugs work

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 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 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 - 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

children 6 to under 12 years of age - 1 to 3 teaspoons (5 - 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

children under 6 years of age - do not use, consult a doctor

Other information

keep tightly closed.  Protect from sunlight

Inactive ingredients

mixed tocopherols (added as a stabilizer)

Adverse reactions

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE, GOODLETTSVILLE, TN37072 USA

MADE IN THE USA WITH US AND FOREIGN COMPONENTS

Principal Display Panel

Since 1903

Rexall

Mineral Oil

Lubricant Laxative

  • For relief of occasional constipation
  • Odorless, tasteless, colorless

SEALED WITH PRINTED SEAL UNDER CAP FOR YOUR PROTECTION

16 FL OZ (1 PT) 473 mL

image description

MINERAL OIL 
mineral oil liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55910-831
Route of AdministrationORAL, TOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL999 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-831-43473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/16/2010
Labeler - DOLGENCORP, LLC (068331990)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(55910-831)

Revised: 7/2013
 
DOLGENCORP, LLC

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