Mineral Oil

Drug Facts

Active Ingredient

Mineral Oil

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 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

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 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

Mineral Oil  Mineral Oil  oil

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-060 Route of Administration TOPICAL, ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Mineral Oil (Mineral Oil) Mineral Oil 15 mL  in 15 mL

Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 36800-060-16 473 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/29/2009

Labeler - Top Care (006935977)

Registrant - Aaron Industries Inc. (030119387)

Establishment
Name	Address	ID/FEI	Operations
Aaron Industries Inc.		030119387	manufacture, analysis

Revised: 11/2009Top Care

More Mineral Oil resources

• Mineral Oil Side Effects (in more detail)
• Mineral Oil Use in Pregnancy & Breastfeeding
• Mineral Oil Drug Interactions
• Mineral Oil Support Group
• 0 Reviews · Be the first to review/rate this drug

• Mineral Oil Monograph (AHFS DI)


• Mineral Oil Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)