MINERAL OIL- mineral oil liquid 
Walgreen Co

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 ad 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: WALGREEN CO  200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com

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WALGREENS PHARMACIST RECOMMENDED

INTESTINAL LUBRICANT

Minerla Oil

Lubricant Laxative

16 FL OZ (1 PT) 473 mL

Walgreens Pharmacist Survery Study, November 2012

TAMPER EVIDENT: DO NOT USE IF THE UNDER CAP PRINTED SAFETY FOIL IS BROKEN OR MISSING

image description

MINERAL OIL 
mineral oil liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0831
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:0363-0831-43 473 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 06/16/1994
Labeler - Walgreen Co (008965063)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(0363-0831)

Revised: 7/2013
Document Id: a6db18ed-e67e-48b7-8c1d-ddda0e6e9350
Set id: 822fd02a-92b0-4010-8bfb-737dba331d54
Version: 1
Effective Time: 20130717
 
Walgreen Co