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Mineral Oil by WAKEFERN FOOD CORPORATION

Medically reviewed on March 5, 2018

Dosage form: liquid
Ingredients: MINERAL OIL 999mg in 1mL
Labeler: WAKEFERN FOOD CORPORATION
NDC Code: 41190-831

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.

Mineral Oil

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 reaction

*This product is not manufactured or distributed by Roberts Pharmaceutical Corp., distributor of Roberts Mineral Oil.

DISTRIBUTED BY WAKEFERN FOOD CORPORATION

5000 RIVERSIDE DR

KEASBEY, NJ, 08832

1-800-SHOPRITE

www.shoprite.com

831.000/831AA

Principal Display Panel

Compare to active ingredient Roberts Mineral Oil

ShopRite

MINERAL OIL USP

LUBRICANT LAXATIVE

For relief of Occasional Constipation

Odorless - Tasteless - Colorless

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

16 FL OZ (1 PT) 473 mL

Made in the USA with US and foreign components

831.000/831AA

MINERAL OIL 
mineral oil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-831
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 Description
1NDC:41190-831-43473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/15/1989
Labeler - WAKEFERN FOOD CORPORATION (069722418)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(41190-831)

 
WAKEFERN FOOD CORPORATION

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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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