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Mineral oil - Medication Information

Product NDC Code 46122-395
Drug Name

Mineral oil

Type Generic
Active Ingredients
Mineral oil 100 mg/100ml
Route ORAL, TOPICAL
Dosage Form OIL
RxCUI drug identifier 343017
Application Number M007
Labeler Name AmerisourceBergen (Good Neighbor Pharmacy) 46122
Packages
Package NDC Code Description
46122-395-16 473 ml in 1 bottle, plastic (46122-395-16)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Mineral Oil 100%

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 to 45 mL) maximum 3 tablespoons (45 mL) in 24 hours children under 12 years, consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient Vitamin E as stabilizer

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.
Uses relieves occasional constipation (irregularity) generally produces bowel movement 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 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 SAFETY SEALED Mineral Oil Lubricant Laxative Odorless-Tasteless Crystal Clear FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by AmerisourceBergen 1 West First Avenue, Conshohocken, PA 19428 www.mygnp.com Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST Package Label GOOD NEIGHBOR PHARMACY Mineral Oil Mineral Oil 100%

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Other Information keep tightly closed protect from direct light

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 persists over a period of 2 weeks

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 in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing if you are presently taking a stool softener laxative for longer than 1 week

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 out of reach of children In case of overdose, get medical help or contact a Poison Control center (1-800-222-1222) right away.

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 feeding
If pregnant or breast feeding, ask a health 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 in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing if you are presently taking a stool softener laxative for longer than 1 week Ask a doctor before use if you have abdominal pain, nausea or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks 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 pregnant or breast feeding, ask a health professional before use Keep out of reach of children In case of overdose, get medical help or contact a Poison Control center (1-800-222-1222) right away.

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