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| Product NDC Code | 48433-202 | ||||
|---|---|---|---|---|---|
| Drug Name | Mineral oil |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 343017 | ||||
| Application Number | part334 | ||||
| Labeler Name | Safecor Health, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Mineral Oil USP
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.Directions: * Do not take with meals. Take only at bedtime. May be taken as a single daily dose or in divided doses. Adults and children 12 years of age and over 1 to 3 Tablespoons (15 mL to 45 mL), maximum 3 Tablespoons (45 mL) in 24 hours Children 6 to under 12 years of age 1 to 3 teaspoons (5 mL to 15 mL), maximum 3 teaspoons (15 mL) in 24 hours Children under 6 years Do not use. Consult a doctor Other information: Keep tightly closed. Protect from sunlight. For more info call 800-447-1006. Inactive ingredients: Mixed tocopherols (added as a stabilizer) NDC: 48433-202-30 Mineral Oil USP 30 mL Unit Dose Cup Mfd. in the U.S.A. Distributed by: Safecor Health, LLC 4060 Business Park Drive, Columbus, OH 43204 Rev: 05/2019 PN5471
| Adults and children 12 years of age and over | 1 to 3 Tablespoons (15 mL to 45 mL), maximum 3 Tablespoons (45 mL) in 24 hours |
| Children 6 to under 12 years of age | 1 to 3 teaspoons (5 mL to 15 mL), maximum 3 teaspoons (15 mL) in 24 hours |
| Children under 6 years | Do not use. Consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Mixed tocopherols (added as a stabilizer) NDC: 48433-202-30 Mineral Oil USP 30 mL Unit Dose Cup Mfd. in the U.S.A. Distributed by: Safecor Health, LLC 4060 Business Park Drive, Columbus, OH 43204 Rev: 05/2019 PN5471
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.Use: For relief of occasional constipation (irregularity). Generally produces bowel movements in 6 to 8 hours
Purpose
Information about the drug product’s indications for use.Purpose Lubricant Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Mineral Oil Mineral Oil MINERAL OIL MINERAL OIL .ALPHA.-TOCOPHEROL
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.Principal Display Panel - Lid Label Delivers 30 mL NDC 48433-202-30 Mineral Oil USP Lubricant Laxative DO NOT TAKE WITH MEALS 348433202302 Pkg By: Safecor Health, LLC Columbus, OH 43204 Principal Display Panel - Lid Label
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 use if you have *abdominal pain, nausea, or vomiting *noticed a sudden change in bowel habits that persist over a period of 2 weeks.
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a Doctor or Pharmacist before use if you are: * presently taking a stool softener * taking any other drug. Take this product 2 or more hours before or after drugs. Laxatives may affect how other drugs work. Frequent or prolonged use may result in dependence.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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.
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.Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. In case of eye contact, flush with water.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information: Keep tightly closed. Protect from sunlight. For more info call 800-447-1006.
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.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product: Do not take with meals. Take only at bedtime.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf breast feeding , ask a health care professional before 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.WARNINGS: 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 persist over a period of 2 weeks. Ask a Doctor or Pharmacist before use if you are: * presently taking a stool softener * taking any other drug. Take this product 2 or more hours before or after drugs. Laxatives may affect how other drugs work. Frequent or prolonged use may result in dependence. 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 care professional before use. Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. In case of eye contact, flush with water.
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