MINERAL OIL- mineral oil liquid 
C.D.M.A.

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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Quality Choice 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?

800-935-2362

Distributed by C.D.M.A., Inc.

43157 W 9 Mile Rd,

 Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

principal display panel

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

QC

QUALITY

CHOICE

Mineral OIl

U.S.P.

Lubricant Laxative

For Relief of Occasional

Constipation

Odorless - Tasteless - Colorless

16 FL OZ (473 mL)

image description

MINERAL OIL 
mineral oil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-831
Route of AdministrationORAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL99.9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-831-43473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/22/2019
Labeler - C.D.M.A. (011920774)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(63868-831)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(63868-831)

Revised: 3/2022
Document Id: 802ec761-8264-4c13-953d-841a863a6d48
Set id: e868a2ac-7648-4626-a8df-7e790736fbe0
Version: 11
Effective Time: 20220314
 
C.D.M.A.