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| Product NDC Code | 0904-6977 | ||||
|---|---|---|---|---|---|
| Drug Name | Hemorrhoidal |
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| Type | Brand | ||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | RECTAL | ||||
| Dosage Form | SUPPOSITORY | ||||
| Application Number | M015 | ||||
| Labeler Name | Major Pharmaceuticals | ||||
| 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.Active Ingredients (in each suppository) Hard Fat 88.44% Phenylephrine hydrochloride 0.25%
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 when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. gently dry by patting or blotting with a tissue or a soft cloth before insertion of suppository. detach on suppository from the strip separate the two tabs of the white plastic wrap with thumb and forefinger of each hand, grasp the tabs and peel downward, unwrapping the suppository insert one suppository into the rectum adults and children 12 years and over: insert one suppository rectally up to 4 times daily children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn starch, methylparaben, propylparaben
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 temporarily shrinks hemorrhoidal tissue gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
Purpose
Information about the drug product’s indications for use.Purpose Protectant Vasoconstrictor
Spl product data elements
Usually a list of ingredients in a drug product.Hemorrhoidal Hard Fat, Phenylephrine HCl STARCH, CORN METHYLPARABEN PROPYLPARABEN HARD FAT HARD FAT PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE
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.The product package shown above represents a sample of that currently in use. Additional packaging may also be available. Major Hemorrhoidal Suppositories 12ct Distributed by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233 Livonia, MI 48152 MajorHemSupp.jpg Major Hem Suppositories
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 heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlargedprostate gland
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 prescription drug for high blood pressure or depression
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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store below 30ºC (86ºF) to avoid melting.
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 bleeding occurs condition worsens or does not improve within 7 days
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 use more than directed
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 For rectal use only Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlargedprostate gland Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression When using this product, do not use more than directed Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, 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