Harris Teeter Oil
FDA Label NDC 69256-831

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter for the product Harris Teeter (NDC 69256-831). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, use, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

mineral oil 99.9%

Purpose

Lubricant laxative

Use

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

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

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.

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 Breast Feeding,

ask a health professional before use

Keep Out Of Reach Of Children

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

Direction

  • do not take with meals
  • take only at bedtime
  • may be taked 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

    childrebn 6 to 12 yeard of age  1 to 3 teaspoons (15 mL) in 24 hours

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

Other Information

keep tightly closed.  Protect from sunlight

Inactive Ingredients

mixed tocopherols (added as a stabilizer)

Questions?

Call 1-888-593-0593

Adverse Reactions

PRODULY DISTRIBUTED BY: HARRIS TEETER, LLC MATTHEWS, NC 28105

1-800-432-6111

Principal Display Panel

Harris Teeter

MINERAL OIL

U.S.P.

LUBRICANT LAXATIVE

FOR RELIEF OF 

OCCASIONAL CONSTIPATION

ODORLESS  

TASTELESS

COLORLESS

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

16 FL OZ (1 PT) 473 mL

Image Description (Mm3)

Image Description (Mm3)

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