MINERAL OIL- mineral oil liquid 
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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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Select Brand  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

  • if you have difficulty swallowing
  • in children under 6 years of age
  • if you are pregnant
  • for a period longer than week
  • if you are bedridden or aged

Ask a doctor before use if you have

  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you are

  • presently taking a stool softener laxative
  • taking any other drug.  Take this product 2 or more hours before or after othr drugs.  Laxatives may affect how other drugs work.

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

  • do not take with meals
  • take only at bedtime
  • may be taken as a single daily dose or in divided doses

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 reaction

Distributed by: SELECT BRANDS DISTRIBUTORS

Pine Bluff, AR 71603   AC (870)535-3635

831.000/831AA

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U.S.P.

MNERAL OIL

Lubricant Laxative

For relief of occasional contipation

ODORLESS - TASTELESS - COLORLESS

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:15127-831
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:15127-831-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/199306/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/25/199306/01/2020
Labeler - Select Brand (012578514)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(15127-831)

Revised: 6/2020
 
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