MINERAL OIL- mineral oil oil 
QUALITY CHOICE (Chain Drug Marketing Association)

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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Drug Facts

Active ingredient

Mineral oil 100%

Purpose

intestinal lubricant

Uses

Warnings

Do not use

  • if you have difficulty swallowing
  • in children under 12 years of age
  • if you are pregnant
  • for a period longer than 1 week
  • if  you are bedridden or aged

Ask a doctor before use if you have

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

When using this product

  • do not take with meals
  • take only at bedtime

Stop use and ask a doctor if

  • rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

 age dose
 adults & children over 12 years1 to 3 tablespoons (15 to 45 mL)
 children under 12 yearsconsult a doctor

Other information

Inactive ingredients

d-alpha tocopherol (Vitamin E) as stabilizer

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Mineral Oil

Lubricant Laxative

Odorless

Tasteless

Colorless

FL OZ (mL)

Distributed by C.D.M.A Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

248-449-9300

Package Label

Mineral Oil 100%

Quality Choice Mineral Oil

MINERAL OIL 
mineral oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-938
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL100 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-938-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/201405/30/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/31/201405/30/2025
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 11/2022
Document Id: ca3086e8-2446-49e4-9816-997ef2e4f9fe
Set id: b53b68de-e2b6-4c8b-b486-2e8aba32a9b6
Version: 5
Effective Time: 20221104
 
QUALITY CHOICE (Chain Drug Marketing Association)