MINERAL OIL- mineral oil liquid 
DZA Brands 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)

Disclaimer

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

Adverse reactions

Disributed by DZA Brands, LLC 2110 Excutive Drive, Salisburg, NC 28147

For product questions or comments contact us at 1-866-322-2439

Please include UPC and code from the package.

Principal display panel

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

healthy

accents

mineral oil

USP

Lubricant laxative

relieves occasional constipationh

odorless - tasteless - colorless

compare to Roberts

Mineral Oil

active ingredient

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 Type HUMAN OTC DRUG Item Code (Source) NDC:55316-831
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:55316-831-43 473 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 10/22/2007
Labeler - DZA Brands LLC (090322194)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(55316-831)

Revised: 7/2013
Document Id: 0e122c91-3aa6-46c3-aa62-f6d3699f84ed
Set id: fe39836b-97db-4472-a1d9-582152443dfa
Version: 1
Effective Time: 20130718
 
DZA Brands LLC