Mineral Oil by Chain Drug Marketing Association / Nice-Pak Products, LLC MINERAL OIL liquid

Mineral Oil by

Drug Labeling and Warnings

Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, Nice-Pak Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Mineral oil 99.9%

Purpose

Lubricant laxative

Use

for relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 8 hours.

Do not use

• if you have difficulty swallowing
• in children under 6 years of age
• if you are pregnant
• for a period longer than week
• if you are bedridden or aged

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

Ask a doctor or pharmacist before use if you are

• presently taking a stool softener laxative
• taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

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 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 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 - 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

children 6 to under 12 years of age - 1 to 3 teaspoons (5 - 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

children under 6 years of age - do not use, consult a doctor

Other information

keep tightly closed. Protect from sunlight.

Inactive ingredients

mixed tocopherols (added as a stabilizer)

Adverse reaction

Distributed by

CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Principal display panel

NDC: 83324-171-16

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

QC®

QUALITY CHOICE

Mineral OIl

U.S.P.

Lubricant Laxative

For Relief of Occasional Constipation

Odorless - Tasteless - Colorless

16 FL OZ (473 mL) 1 PT

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-171
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	999 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-171-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	07/02/2024

Labeler - Chain Drug Marketing Association (011920774)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(83324-171)