Mineral Oil Usp

Mineral Oil Usp
SPL v3
SPL
SPL Set ID 960502ae-2468-406e-8799-cacb01f2727e
Route
ORAL
Published
Effective Date 2024-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (999 mg)
Inactive Ingredients
Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-17

Description

Distributed by: McKesson Corp. Via Strategic Services LLC. Memphis, TN 38141  Money Back Guarantee www.fosterandthrive.com

Purpose

Lubricant laxative


Medication Information

Purpose

Lubricant laxative

Description

Distributed by: McKesson Corp. Via Strategic Services LLC. Memphis, TN 38141  Money Back Guarantee www.fosterandthrive.com

Use

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

Section 42229-5

Distributed by: McKesson Corp. Via Strategic Services LLC.

Memphis, TN 38141 

Money Back Guarantee

www.fosterandthrive.com

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 1 week 
  • if you are bedridden or aged
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 under 12 years of age - 1 to 3 teaspoons (5 to 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

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

Active Ingredient

Mineral oil 99.9% 

Other Information

keep tightly closed. Protect from sunlight.

If Breast Feeding,

ask a health professional before use.

Inactive Ingredients

mixed tocopherols (added as a stabilizer)

Principal Display Panel

NDC 17856-1110-01

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.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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.

Structured Label Content

Use

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

Section 42229-5 (42229-5)

Distributed by: McKesson Corp. Via Strategic Services LLC.

Memphis, TN 38141 

Money Back Guarantee

www.fosterandthrive.com

Purpose

Lubricant laxative

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 1 week 
  • if you are bedridden or aged
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 under 12 years of age - 1 to 3 teaspoons (5 to 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

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

Active Ingredient (Active ingredient)

Mineral oil 99.9% 

Other Information

keep tightly closed. Protect from sunlight.

If Breast Feeding, (If breast-feeding,)

ask a health professional before use.

Inactive Ingredients (Inactive ingredients)

mixed tocopherols (added as a stabilizer)

Principal Display Panel

NDC 17856-1110-01

When Using This Product (When using this product)

do not take with meals. Take only at bedtime.

Stop Use and Ask A Doctor If (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.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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 (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.

Advanced Ingredient Data


Raw Label Data

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