Mineral Oil by Family Dollar (FAMILY WELLNESS) MINERAL OIL oil

Mineral Oil by

Drug Labeling and Warnings

Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Family Dollar (FAMILY WELLNESS). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Mineral Oil 100%

Purpose

Lubricant laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 6 to 8 hours

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

• 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 to 45 mL)
  • maximum 3 tablespoons (45 mL) in 24 hours
• children under 12 years, consult a doctor 

Other Information

• keep tightly closed
• protect from direct light

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

FAMILY WELLNESS Mineral Oil

 

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-634
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	100 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-634-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	06/30/2017

Labeler - Family Dollar (FAMILY WELLNESS) (024472631)