MINERAL OIL- mineral oil liquid 
DOLGENCORP, LLC

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 99.9%

Purpose

Lubricant laxative

Use

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

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

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

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:55910-831
Route of Administration ORAL, TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 999 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55910-831-43 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 09/16/2010
Labeler - DOLGENCORP, LLC (068331990)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(55910-831)

Revised: 7/2013
Document Id: 4bd4c3bf-342b-4541-8efd-4d482f85ace6
Set id: 4bae831d-caba-40c9-bdb5-2611eac35dd5
Version: 1
Effective Time: 20130718
 
DOLGENCORP, LLC