MINERAL OIL- mineral oil liquid 
WAKEFERN FOOD CORPORATION

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)

Disclaimer

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

Adverse reactions

DISTRIBUTED BY WAKEFERN FOOD CORPORATION

5000 RIVERSIDE DR

KEASBEY, NJ, 08832

1-800-SHOPRITE

www.shoprite.com

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Compare to active ingredient Roberts Mineral Oil

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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

image description

MINERAL OIL 
mineral oil liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Vi-Jon790752542manufacture(41190-831)

Revised: 7/2013
Document Id: a698b339-c2a6-4980-8fbc-948e619d9306
Set id: 51285b14-2751-4c72-ac09-72357c58c289
Version: 1
Effective Time: 20130718
 
WAKEFERN FOOD CORPORATION