Mineral oil by QUALITY CHOICE (Chain Drug Marketing Association) MINERAL OIL oil

Mineral oil by

Drug Labeling and Warnings

Mineral oil by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (Chain Drug Marketing Association). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Mineral oil 100%

Purpose

intestinal lubricant

Uses

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

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

• do not take with meals
• take only at bedtime
• may be taken as a single daily dose or in divided doses

• age: dose
• adults & children over 12 years: 1 to 3 tablespoons (15 to 45 mL)
• children under 12 years: consult a doctor

Other information

• keep tightly closes
• protect from sunlight

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

Quality Choice Mineral Oil

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-938
Route of Administration	ORAL

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: 63868-938-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	07/31/2014

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)