Mineral Oil

Pronunciation

Dosage Form: oral oil

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredient

Mineral Oil

intestinal lubricant

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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

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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 Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:36800-060-16 473 mL in 1 BOTTLE, PLASTIC
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: 11/2009
 
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