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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Soothe Night Time
Generic Name
White Petrolatum Mineral Oil
Active Ingredient
Mineral OilCategory
Amide Local Anesthetic [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 200 mg/g | OINTMENT | OPHTHALMIC | 24208-313 |
Detailed information about Soothe Night Time
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Soothe Night Time, you must consult a qualified healthcare professional.
Mineral Oil is a lubricant laxative and emollient used to treat occasional constipation and dry skin conditions. It works by retaining water in the stool and intestinal tract, facilitating easier passage through the colon.
For the treatment of occasional constipation in adults and children 12 years of age and older:
Mineral Oil must be used with extreme caution in children due to the risk of aspiration.
Because Mineral Oil is not absorbed and does not rely on renal clearance, dosage adjustments for patients with kidney disease are generally not required. However, these patients should be monitored for secondary electrolyte changes if they experience diarrhea.
No specific dosage adjustments are required for patients with liver disease, as the drug is not metabolized by the liver. However, caution is advised in patients with severe cirrhosis who may have impaired swallowing reflexes.
Geriatric patients are at a significantly higher risk for aspiration pneumonia. Healthcare providers often recommend avoiding oral Mineral Oil in patients who are frail, bedridden, or have difficulty swallowing. Rectal administration is often a safer alternative for this population.
To ensure safety and efficacy, follow these guidelines:
If you miss a dose, take it as soon as you remember. However, if it is nearly time for your next dose or if it is close to bedtime, skip the missed dose and resume your regular schedule. Do not double the dose to catch up.
An acute overdose of Mineral Oil primarily results in gastrointestinal distress. Symptoms may include:
In the event of an overdose, contact a Poison Control Center or seek emergency medical care immediately. The primary concern with large ingestions is the risk of aspiration and subsequent lipid pneumonia.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or use this product for more than 7 consecutive days without medical guidance.
While Mineral Oil is generally well-tolerated when used correctly, the following common side effects may occur:
> Warning: Stop taking Mineral Oil and call your doctor immediately if you experience any of these symptoms:
Chronic use of Mineral Oil (longer than one week) can lead to significant health complications:
There are currently no FDA black box warnings for Mineral Oil. However, the FDA requires strict labeling warnings regarding the risk of aspiration and the prohibition of use in children under 6, pregnant women, and the elderly without medical supervision.
Report any unusual symptoms to your healthcare provider. You may also report side effects to the FDA at 1-800-FDA-1088.
Mineral Oil should only be used as a short-term solution for constipation. It is not a permanent fix for chronic bowel issues. Patients should be aware that the primary risk associated with this medication is not systemic toxicity, but rather mechanical complications such as aspiration and nutrient malabsorption.
No FDA black box warnings for Mineral Oil.
For short-term OTC use, regular lab monitoring is generally not required. However, for patients using it under medical supervision for longer periods, doctors may monitor:
Mineral Oil does not have any known psychoactive effects and does not cause drowsiness. It is generally safe to drive or operate machinery after taking this medication. However, the potential for sudden bowel urgency or anal leakage should be considered.
There is no direct chemical interaction between alcohol and Mineral Oil. However, alcohol can contribute to dehydration, which worsens constipation. It is recommended to limit alcohol intake while treating bowel irregularities.
Mineral Oil can be stopped abruptly without the physiological withdrawal symptoms seen with certain drugs. However, if you have been using it for an extended period, you may experience 'rebound constipation' as your bowel adjusts to the lack of lubrication. It is best to gradually increase dietary fiber and fluid intake while tapering off laxatives.
> Important: Discuss all your medical conditions, including any history of swallowing problems or lung disease, with your healthcare provider before starting Mineral Oil.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking to prevent dangerous interactions.
Mineral Oil must NEVER be used in the following circumstances:
Conditions requiring careful risk-benefit analysis by a physician:
There is no known cross-sensitivity between Mineral Oil and other classes of laxatives (like stimulants or osmotics). However, patients with a known hypersensitivity to petroleum-derived products should use Mineral Oil with caution, although true allergic reactions are extremely rare.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Mineral Oil to ensure it is the safest option for you.
Mineral Oil is generally not recommended during pregnancy. The primary concern is the inhibition of Vitamin K absorption. Vitamin K is essential for the synthesis of clotting factors. If the mother becomes deficient, the fetus may be born with a dangerous tendency to bleed (hemorrhagic disease of the newborn). Additionally, chronic use of laxatives can lead to electrolyte imbalances that are harmful during pregnancy. Always consult an obstetrician before using any laxative.
Mineral Oil is not absorbed systemically in significant amounts and is therefore unlikely to be excreted into breast milk. However, because it can interfere with the mother's nutritional status (specifically fat-soluble vitamins), it should be used only sparingly and under medical advice. There are no known direct effects on the nursing infant, but maternal health is paramount for quality milk production.
In the elderly, the risks of Mineral Oil often outweigh the benefits. The risk of aspiration pneumonia is significantly elevated due to age-related changes in swallowing and the increased likelihood of being in a recumbent (lying down) position. Furthermore, elderly patients are more likely to be taking multiple medications (polypharmacy), such as Warfarin or Digoxin, which interact with Mineral Oil. Safer alternatives like polyethylene glycol (Miralax) are usually preferred.
Mineral Oil is safe for patients with renal impairment as it does not enter the bloodstream or require kidney filtration. However, these patients must be careful to maintain hydration, as any laxative-induced diarrhea can cause rapid shifts in fluid balance that the kidneys may struggle to manage.
Patients with liver disease (cirrhosis or hepatitis) can use Mineral Oil, but they should be monitored for Vitamin K deficiency. Since the liver produces clotting factors using Vitamin K, any reduction in vitamin absorption can exacerbate existing coagulopathy (bleeding problems) associated with liver failure.
> Important: Special populations require individualized medical assessment to avoid complications.
Mineral Oil is a pharmacologically inert substance. Its primary mechanism is mechanical lubrication. By coating the intestinal mucosa and the fecal mass with a hydrophobic film, it prevents the colonic reabsorption of water. This keeps the stool hydrated and soft. Unlike stimulant laxatives (e.g., senna), it does not stimulate the myenteric plexus or increase intestinal secretions. It simply makes the existing stool 'slippery' enough to pass with minimal effort.
| Parameter | Value |
|---|---|
| Bioavailability | <5% (Minimal) |
| Protein Binding | N/A (Not systemically active) |
| Half-life | N/A (Physical transit time 6-12 hours) |
| Tmax | N/A (Local action) |
| Metabolism | None |
| Excretion | Fecal (>95% unchanged) |
Mineral Oil is classified as a Lubricant Laxative. It is distinct from Bulk-forming laxatives (fiber), Osmotic laxatives (magnesium citrate), and Stimulant laxatives (bisacodyl). In some regulatory contexts, it is also listed as an emollient or a pharmaceutical solvent.
Common questions about Soothe Night Time
Mineral Oil is primarily used as a lubricant laxative to treat occasional constipation and to prevent straining during bowel movements. It is particularly helpful for individuals with hemorrhoids or those recovering from surgery who need to pass stool easily. Additionally, it is used topically as an emollient to treat dry, scaly skin conditions by trapping moisture in the skin. Some people also use it rectally as an enema to clear fecal impaction. It should only be used for short-term relief and not as a long-term solution for bowel regularity. Always consult a healthcare provider to determine the underlying cause of persistent constipation.
The most common side effects of Mineral Oil include anal seepage, where the oil leaks from the rectum and may stain clothing, and perianal irritation or itching. Some users may also experience mild abdominal cramping, nausea, or bloating after taking an oral dose. Because the oil is not absorbed, it can cause the stool to become very soft or oily. If taken in excessive amounts, it can lead to diarrhea and subsequent dehydration. These side effects are generally mild and resolve once the oil has passed through the system. However, if you experience severe pain or persistent leakage, you should contact your doctor.
There is no known direct chemical interaction between alcohol and Mineral Oil that would cause a dangerous reaction. However, alcohol is a known dehydrator and can interfere with healthy bowel function, potentially making constipation worse. Drinking alcohol while trying to treat constipation may counteract the benefits of the laxative. Furthermore, excessive alcohol consumption can impair your coordination and swallowing reflex, which increases the dangerous risk of aspirating the oil into your lungs. For these reasons, it is best to limit or avoid alcohol while using Mineral Oil for digestive issues. Always prioritize hydration with water instead.
Mineral Oil is generally considered unsafe for use during pregnancy unless specifically recommended by a doctor. The main concern is that it can interfere with the mother's absorption of fat-soluble vitamins, particularly Vitamin K. A deficiency in Vitamin K can lead to serious bleeding complications for both the mother and the newborn baby. Additionally, some healthcare providers worry that the use of lubricant laxatives could theoretically stimulate uterine contractions. Safer alternatives for constipation during pregnancy, such as increased fiber or stool softeners like docusate (when not combined with oil), are usually preferred. Always talk to your obstetrician before taking any medication while pregnant.
When taken orally, Mineral Oil typically produces a bowel movement within 6 to 8 hours. Because of this timeframe, many people choose to take it in the morning, though it should never be taken right before lying down for sleep. If administered rectally as an enema, the onset of action is much faster, usually occurring within 2 to 15 minutes. The exact time can vary depending on the individual's metabolism and the severity of the constipation. If you do not have a bowel movement after using Mineral Oil for a day or two, you should stop use and consult a healthcare professional. Do not increase the dose without medical advice.
Yes, you can stop taking Mineral Oil suddenly without experiencing traditional withdrawal symptoms, as it is not a systemic drug. However, if you have been using it frequently, your bowels may have become reliant on the lubrication to pass stool. This can result in 'rebound constipation' where your symptoms return or temporarily worsen after you stop. To avoid this, it is recommended to gradually increase your intake of natural fiber and water while you stop using the oil. If you find that you cannot have a bowel movement without the use of a laxative, you should see a doctor to check for underlying issues. Mineral Oil is intended for short-term use only (less than 7 days).
If you miss a dose of Mineral Oil, you should take it as soon as you remember, provided it is not close to your next scheduled dose or your bedtime. If it is late in the evening, it is safer to skip the missed dose entirely to avoid the risk of aspiration while lying down. Never take a double dose to make up for a missed one, as this can lead to severe anal seepage and abdominal cramps. Simply resume your regular dosing schedule the following day. If your constipation is severe and skipping a dose causes discomfort, contact your healthcare provider for guidance. Consistency is helpful, but safety regarding positioning is more important.
Mineral Oil does not cause weight gain because it is not absorbed or metabolized by the body as a source of calories. Unlike vegetable oils, which are fats that the body can use for energy, mineral oil passes through the digestive tract unchanged. In fact, chronic use of Mineral Oil can actually lead to weight loss or malnutrition because it prevents the absorption of essential fat-soluble vitamins and nutrients. This is a negative side effect rather than a healthy weight-loss method. Using laxatives for weight control is dangerous and can lead to severe eating disorders and electrolyte imbalances. If you are concerned about your weight, discuss a healthy diet and exercise plan with your doctor.
Mineral Oil can significantly interfere with the absorption of many other medications. Because it coats the stomach and intestines, it can prevent oral drugs like birth control pills, blood thinners (Warfarin), and heart medications (Digoxin) from entering your system. It is also strictly forbidden to take Mineral Oil with stool softeners like docusate, as this can cause the oil to be absorbed into your organs. To minimize interactions, you should take Mineral Oil at least 2 hours before or after any other medication. Always provide your doctor or pharmacist with a full list of all supplements and drugs you are taking. This ensures that your other treatments remain effective while you treat your constipation.
Yes, Mineral Oil is widely available as a generic product and is often significantly less expensive than brand-name laxatives. It is sold under various labels in pharmacies, grocery stores, and big-box retailers, usually found in the digestive health or first aid aisle. When buying generic Mineral Oil for internal use, ensure the label specifies that it is 'USP' (United States Pharmacopeia) grade and intended for use as a laxative. Some mineral oils are intended for industrial or topical use only and may contain impurities that are not safe to swallow. The generic version is chemically identical to the active ingredient in brand-name lubricant laxatives and works the same way.
Other drugs with the same active ingredient (Mineral Oil)