MINERAL OIL- mineral oil oil 
Amazon.Com Services 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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Mineral Oil
831.000_831AA

Active ingredient

Mineral oil 99.9%

Purpose

Lubricant laxative

Use

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

Warnings

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 signd of 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 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

children 6 to 12 years of age - 1 to 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)

DISTRIBUTED BY:

Amazon.com, Services, Inc

Seattle, WA 98109

1-877-485-0385

2018 Amazon.com, Inc. or its afiliated.

All rights reserved. Solimo and all related logos are are trademarks of

Amazon.com, Inc or its affiliates.

831.000/831AA

principal display panel

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION.

SOLIMO

MINERAL OIL U.S.P.

LUBRICANT LAXATIVE

Odorless tasteless colorless

16 FL OZ (1 PT) 473 mL

image description

MINERAL OIL 
mineral oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-831
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72288-831-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/2018
Labeler - Amazon.Com Services LLC (128990418)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(72288-831)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(72288-831)

Revised: 8/2022
Document Id: 972ac02d-a179-4c53-9966-0ec25123707f
Set id: 431225c5-a2a4-47e2-a6e9-4248eb80f9fd
Version: 3
Effective Time: 20220804
 
Amazon.Com Services LLC