Mineral Oil by TOP CARE (Topco Associates LLC) MINERAL OIL oil

Mineral Oil by

Drug Labeling and Warnings

Mineral Oil by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). 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

Principal Display Panel

Mineral Oil

LUBRICANT LAXATIVE

• For Relief of Occasional Constipation
• Odorless
• Tasteless
• Colorless

FL OZ (mL)

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

www.topcarebrand.com

Questions or comments? Call toll free 1-888-423-0139

Package Label

TOPCARE HEALTH Mineral Oil

 

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-334
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: 36800-334-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	11/30/2016

Labeler - TOP CARE (Topco Associates LLC) (006935977)