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Humco mineral oil heavy - Medication Information

Product NDC Code 0395-1685
Drug Name

Humco mineral oil heavy

Type Brand
Active Ingredients
Mineral oil 1000 mg/ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 311714
Application Number M007
Labeler Name Humco Holding Group, Inc.
Packages
Package NDC Code Description
0395-1685-28 3800 ml in 1 bottle, plastic (0395-1685-28)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Mineral Oil Heavy

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 Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime. Children 6 to 12 yrs. of age: 1 to 3 teaspoonfuls 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.
Inactive ingredient 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.
Use For relief of occasional constipation or irregularit. Generally produces bowel movement in 6 to 8 hrs.

Purpose

Information about the drug product’s indications for use.
Purpose Laxative

Spl product data elements

Usually a list of ingredients in a drug product.
Humco Mineral Oil Heavy 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.
Principal display panel capture(2)

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.
Drug Facts

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 are currently taking a stool softener laxative. If pregnant or brest feeding ask a health professional before use.

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 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.
Other information Keep tightly closed and protect 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.
When using this Product discotinue use and consult a doctor if there is a failure 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.
Warnings Do not take this product if you have abdominal pain, nausea, vomiting, change in bowel habits persisting more than 2 weeks, rectal bleeding or kidney failure are present, or use for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives. Do not administer to infants or young children, bedridden or aged patients unless directed by a doctor.

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