Mineral Oil

Mineral Oil

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Questions & Answers

Side Effects & Adverse Reactions

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.

ECG changes including QT interval prolongation has been seen in patients receiving ondansetron. In addition, postmarketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron in patients with congenital long QT syndrome. ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation. 

The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists alone. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of ondansetron alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.

Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of ondansetron and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue ondansetron and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ondansetron is used concomitantly with other serotonergic drugs (see PRECAUTIONS and OVERDOSAGE).

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


  1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2.
  2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
  3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
  4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron orally disintegrating tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.


There is currently no drug history available for this drug.

Other Information

The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula:

Chemical Structure

The molecular formula is C18H19N3O representing a molecular weight of 293.4. Ondansetron is a white to off-white powder.

Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.

This product does not meet USP Disintegration Time. The 4 mg and 8 mg tablets disintegrate in approximately 60 seconds.

Mineral Oil Manufacturers

  • Western Family Foods, Inc.
    Mineral Oil Liquid [Western Family Foods, Inc.]
  • Rebel Distributors Corp
    Mineral Oil (Lacri-lube) Ointment [Rebel Distributors Corp]
  • Cvs Pharmacy
    Mineral Oil, Pramoxine Hydrochloride And Zinc Oxide Cream [Cvs Pharmacy]
  • Cardinal Health
    Mineral Oil Liquid [Cardinal Health]
  • Shopko Stores Operating Co., Llc
    Mineral Oil Liquid [Shopko Stores Operating Co., Llc]
  • Axcentria Pharmaceuticals, Llc
    Mineral Oil, Petrolatum And Phenylephrine Hcl (Mineral Oil, Petrolatum, Phenylephrine Hcl) Ointment [Axcentria Pharmaceuticals, Llc]
  • Walgreen Co
    Mineral Oil Liquid [Walgreen Co]
  • Target Corp
    Mineral Oil Liquid [Target Corp]
  • Select Brand
    Mineral Oil Liquid [Select Brand]
  • Kroger Co
    Mineral Oil Liquid [Kroger Co]
  • Dolgencorp, Llc
    Mineral Oil Liquid [Dolgencorp, Llc]
  • Dza Brands Llc
    Mineral Oil Liquid [Dza Brands Llc]
  • Wakefern Food Corporation
    Mineral Oil Liquid [Wakefern Food Corporation]
  • Ameri-vet
    Mineral Oil, Light (Mineral Oil) Liquid [Ameri-vet]
  • Safeway
    Mineral Oil Liquid [Safeway]
  • Geiss, Destin & Dunn, Inc
    Mineral Oil Liquid [Geiss, Destin & Dunn, Inc]
  • Durvet, Inc.
    Mineral Oil (Light Mineral Oil) Oil [Durvet, Inc.]
  • Supervalu, Inc
    Mineral Oil Liquid [Supervalu, Inc]
  • Paddock Laboratories, Llc
    Mineral Oil Liquid [Paddock Laboratories, Llc]

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