MINERAL OIL- mineral oil liquid 
Shopko Stores Operating Co., 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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Shopko 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 ad ask a doctor 

if you have rectal bleeding or failure to have a bowel movement after use.  The coudlbe 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 ad 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)

Made in the USA with US and foreign components

Manufactured by Vi-Jon, Inc

One Swan Drive, Smyrna, TN 37167

for ShopKo Stores Operating Co. LLC

principal display panel

SHOPKO

Mineral

Oil

U.S.P.

Lubricant Laxative

For Relief of Occasional Constipation

Sealed with printed foil under cap for your protection

16 FL OZ (1 PT) 473 mL

image description

MINERAL OIL 
mineral oil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-831
Route of AdministrationORAL, TOPICAL
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:37012-831-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/02/2008
Labeler - Shopko Stores Operating Co., LLC (023252638)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(37012-831)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(37012-831)

Revised: 3/2022
Document Id: e8dc0c1c-b41b-4ea1-8249-94355741e59d
Set id: e71e8fae-197b-4eb8-be86-c752e9af3f33
Version: 12
Effective Time: 20220316
 
Shopko Stores Operating Co., LLC