MINERAL OIL- mineral oil oil 
Family Dollar (FAMILY WELLNESS)

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

Lubricant laxative

Uses

Warnings

Do not use

  • in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing
  • if you are presently taking a stool softener laxative
  • for longer than 1 week

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

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 pregnant or 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 (1-800-222-1222) right away.

Directions

Other Information

Inactive Ingredient

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 and Colorless

For Relief of Occasional Constipation (Irregularity)

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

10611 MONROE RD., MATTHEWS, NC 28105

Package Label

Mineral Oil 100%

FAMILY WELLNESS Mineral Oil

 

MINERAL OIL 
mineral oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-634
Route of AdministrationORAL, TOPICAL
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:55319-634-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201706/30/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/30/201706/30/2025
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 10/2022
Document Id: 65ef7143-a71d-400a-ae9c-6d293d22a90b
Set id: 14f40d7a-fff8-4488-93e6-9a835f1efd91
Version: 4
Effective Time: 20221031
 
Family Dollar (FAMILY WELLNESS)