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| Product NDC Code | 70000-0448 | ||||
|---|---|---|---|---|---|
| Drug Name | Leader mineral oil |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 343017 | ||||
| Application Number | M007 | ||||
| Labeler Name | Cardinal Health, 110 dba Leader | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Mineral Oil
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime. Children 6 to 12 yes of age: 1 to 3 teaspoonfulls at bedtime. Children under 6 yrs of age: Consult a doctor before use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.dl-alpha-tocopherol as a preservative
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.For relief of occasional constpation or irregularity. Generally produces bowel movement in 6 to 8 hours.
Purpose
Information about the drug product’s indications for use.Lubricant Laxative
Spl product data elements
Usually a list of ingredients in a drug product.LEADER Mineral Oil Mineral Oil .ALPHA.-TOCOPHEROL ACETATE, DL- MINERAL OIL MINERAL OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.mineraloil
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before usage if you hav abdominal pain, nausea, or vomiting, noticed a sudden change in bowel habits that persists over a period of 2 weeks.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Keep tightly closed and protected from direct light
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.and consult a doctor if there is a fialure to have a bowel movement after use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Do not use if you have difficulty swallowing, in children under 12 years of age, if you are pregnant, for a period longer than 1 week, if you are bedridden or aged, if you are presently taking a stool softener laxative
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API