Walgreens 831.000/831aa

Walgreens 831.000/831aa
SPL v16
SPL
SPL Set ID 822fd02a-92b0-4010-8bfb-737dba331d54
Routes
ORAL TOPICAL
Published
Effective Date 2025-04-07
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 1994-06-16

Description

DISTRIBUTED BY: WALGREEN CO., DEERFEILD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com ©2023 Walgreen Co. Walgreens Pharmacist Recommended. *Contains less than 20ppm of gluten

Purpose

Lubricant laxative


Medication Information

Purpose

Lubricant laxative

Description

DISTRIBUTED BY: WALGREEN CO., DEERFEILD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com ©2023 Walgreen Co. Walgreens Pharmacist Recommended. *Contains less than 20ppm of gluten

Use

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

Other

NDC 0363-0831-43

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

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
Questions?

Call 1-888-593-0593

Adverse Reaction

DISTRIBUTED BY: WALGREEN CO., DEERFEILD, IL 60015

100% SATISFACTION GUARANTEED walgreens.com ©2023 Walgreen Co.

Walgreens Pharmacist Recommended.

*Contains less than 20ppm of gluten

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)

When Using This Product

do not take with meals.  Take only at bedtime.

Principal Display Panel

Walgreens

free+pure†

Mineral Oil

Tasteless • Odorless • Colorless

Intestinal lubricant laxative

For relief of occasional constipation

†Free + Pure is:

  • No artificial flavors
  • No synthetic colors
  • Gluen free*
  • Non-GMO

16 FL OZ (1 PT) 473 mL

TAMPER EVIDENT: DO NOT USE IF THE PRINTED FOIL UNDER CAP IS BROKEN OR MISSING

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.

n 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.

Other

NDC 0363-0831-43

Purpose

Lubricant laxative

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

Do Not Use (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
Questions?

Call 1-888-593-0593

Adverse Reaction (Adverse reaction)

DISTRIBUTED BY: WALGREEN CO., DEERFEILD, IL 60015

100% SATISFACTION GUARANTEED walgreens.com ©2023 Walgreen Co.

Walgreens Pharmacist Recommended.

*Contains less than 20ppm of gluten

Active Ingredient (Active ingredient)

Mineral oil 99.9%

Other Information (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)

When Using This Product (When using this product)

do not take with meals.  Take only at bedtime.

Principal Display Panel (principal display panel)

Walgreens

free+pure†

Mineral Oil

Tasteless • Odorless • Colorless

Intestinal lubricant laxative

For relief of occasional constipation

†Free + Pure is:

  • No artificial flavors
  • No synthetic colors
  • Gluen free*
  • Non-GMO

16 FL OZ (1 PT) 473 mL

TAMPER EVIDENT: DO NOT USE IF THE PRINTED FOIL UNDER CAP IS BROKEN OR MISSING

Stop Use and Ask A Doctor (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.)

n 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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