PREMIER VALUE- mineral oil 
Pharmacy Value Alliance 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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Premier Value Mineral Oil  831.000/831AA

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)

Questions?

Call 1-888-593-0593

Adverse Reaction

Distributed by: Pharmacy Value Alliance LLC

407 East Lancaster Avenue, Wayne, PA 19087   www.emersongroup.com

If for any reason you are not satisfied with this product,

please return it to the store where purchased for a full refund.

principal display panel

Premier

Value

Mineral Oil usp

lubricant laxative

odorless - tasteless - colorless

for relief of occasional constipation

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

16 FL OZ (1PT) 473 mL

image description

PREMIER VALUE 
mineral oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-831
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL999 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-831-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/19/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/19/2009
Labeler - Pharmacy Value Alliance LLC (101668460)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(68016-831)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(68016-831)

Revised: 3/2022
Document Id: 81a66df0-7a28-4849-bea9-9624e409fdb5
Set id: 95e63e4e-75e0-4439-bb4d-12b8062ce5c1
Version: 9
Effective Time: 20220311
 
Pharmacy Value Alliance LLC