Up & Up 831.000/831aa

Up & Up 831.000/831aa
SPL v19
SPL
SPL Set ID 526508f0-e908-4e3d-88f5-404a95f6de76
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 1996-12-12

Description

Mineral oil 99.9%

Purpose

Lubricant laxative

Adverse Reactions

Dist. by Target Corp., Mpls, MN 55403 TM & ©2024 Target Brands, Inc.


Medication Information

Purpose

Lubricant laxative

Adverse Reactions

Dist. by Target Corp., Mpls, MN 55403

TM & ©2024 Target Brands, Inc.

Description

Mineral oil 99.9%

Use

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

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 week
  • if you are bedridden or aged
Questions?

Call 1-800-910-6874

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

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

NDC 11673-831-43

Lubricant Laxative

Mineral Oil USP

  • Helps relieve occasional constipation
  • Tasteless, colorless, odorless

up & up ™

16 FL OZ (1 PT) 473 mL

When Using This Product

do not take with meals. Take only at bedtime.

Stop Use Ad 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.

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 week
  • if you are bedridden or aged
Questions?

Call 1-800-910-6874

Active Ingredient (Active ingredient)

Mineral oil 99.9%

Adverse Reactions (Adverse reactions)

Dist. by Target Corp., Mpls, MN 55403

TM & ©2024 Target Brands, Inc.

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)

Principal Display Panel (Principal display panel)

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

NDC 11673-831-43

Lubricant Laxative

Mineral Oil USP

  • Helps relieve occasional constipation
  • Tasteless, colorless, odorless

up & up ™

16 FL OZ (1 PT) 473 mL

When Using This Product (When using this product)

do not take with meals. Take only at bedtime.

Stop Use Ad Ask A Doctor  (Stop use ad 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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