Mineral Oil
FDA Label NDC 54162-175

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Mineral Oil (NDC 54162-175). 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 ask a doctor before using laxative if you:, ​when using this product, do not use more than directed., ​stop using this product and consult a doctor if you:, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, storage and handling, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Ask A Doctor Before Using Laxative If You:

  • Have nausea, vomiting, or abdominal pain
  • Have suddent change in bowel habits lasting more than two weeks
  • Have already used a laxative for more than 1 week


    • ​Ask a doctor of pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

​When Using This Product, Do Not Use More Than Directed.

Serious side effects may occur from excess dosage.

​Stop Using This Product And Consult A Doctor If You:

  • Have rectal bleeding
  • Have no bowel movemenet after the enema is given

    • These symptoms may indicated a serious condition.

Otc - Pregnancy Or Breast Feeding

​If pregnant or breastfeeding​ ​ ​Ask a health professional before use.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN
In the case of accidental ingestion contact a Poison Control Center right away

Dosage & Administration

Remove orange protective shield before inserting by holding bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove, then insert lubricated tip into rectum and squeeze gently.

Storage And Handling

Store at room temperature 59°-86°F (15°-30°C)

Package Label.Principal Display Panel



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