MINERAL OIL- mineral oil liquid 
DOLGENCORP, 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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Rexall 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)

DISTRIBUTED BY OLD EAST MAIN CO

GOODLETTSVILLE, TN 37072 USA

MADE IN THE USA WITH US AND FOREIGN COMPONENTS

831.000/AA

PRINCIPAL DISPLAY PANEL

Since 1903

Rexall

Mineral oil U.S.P.

Lubricant Laxative

SEALED WITH PRINTED SEAL 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:55910-831
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:55910-831-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/16/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/16/2010
Labeler - DOLGENCORP, LLC (068331990)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55910-831)

Revised: 3/2021
Document Id: f29f3ed2-bbd0-4841-a84c-e69c977a7bb4
Set id: 4bae831d-caba-40c9-bdb5-2611eac35dd5
Version: 8
Effective Time: 20210322
 
DOLGENCORP, LLC