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Mineral Oil Prescribing Information

Package insert / product label
Dosage form: oral oil
Drug class: Laxatives

Medically reviewed by Drugs.com. Last updated on Mar 24, 2023.

Active Ingredient

Mineral Oil

intestinal lubricant

Indications and Usage for Mineral Oil

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 6 years of age

if you are pregnant

for a period longer than one 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


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 this and all drugs out of the reach of children

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately

Mineral Oil Dosage and Administration

do not take with meals

take only at bedtime

may be taken as a single daily dose or in divided doses

age dose

adults and children over 12 years 1 to 3 tablespoons (15 to 45 ml)

maximum3 tablespoons (45mL) in 24 hours



children 6 years to under 12 years 1 to 3 tablespoons (15 to 45 ml)

maximum3 tablespoons (45mL) in 24 hours

children under 6 years do not use, consult a doctor

Other Information

keep tightly closed

protect from sunlight


Inactive Ingredient

d-alpha tocopherol (Vitamin E) as stabilizer

Principal Display Panel

Topcare

Extra Heavy

Mineral

Oil USP

Lubricant Laxative

Tasteless Colorless Odorless


16 FL OZ 1PT 473mL
image of label

MINERAL OIL
mineral oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-060
Route of AdministrationTOPICAL, ORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL15 mL in 15 mL
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-060-16473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/29/2009
Labeler - Top Care (006935977)
Registrant - Aaron Industries Inc. (030119387)
Establishment
NameAddressID/FEIBusiness Operations
Aaron Industries Inc.030119387manufacture, analysis