Mineral Oil by Consumer Product Partners, LLC MINERAL OIL oil

Mineral Oil by

Drug Labeling and Warnings

Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Consumer Product Partners, 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 productes bowel movement in 6 to 8 hours.

Warnings

for this product

Do not use

• if you have difficulty swallowing
• in children under 6 years of age
• if you are pregnant
• for a period of longer than 1 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 wrok.

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

children 6 to 12 years of age - 1 to 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: Consumer Product Partners, LLC

St. Louis, MO 63114  1-888-593-0593

Principal display panel

SWAN ®

MINERAL OIL

U.S.P. LUBRICANT LAXATIVE

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

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION.

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-831
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: 11344-831-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	04/30/2024

Labeler - Consumer Product Partners, LLC (119091520)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(11344-831)