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| Product NDC Code | 68016-322 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | Pharmacy Value Alliance LLC | ||||||
| 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 (per suppository) Cocoa butter 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 Adults detach one suppository from the strip. Remove the wrapper before inserting into the rectum insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement children under 12 years of age: consult 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 aids in protecting irritated anorectal areas
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 Cocoa Butter, Phenylephrine HCl STARCH, CORN METHYLPARABEN PROPYLPARABEN COCOA BUTTER COCOA BUTTER 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 below represents a sample of that currently in use. Additional packaging may also be available. Premier Value Hemorrhoidal Suppositories 12ct Distributed by Pharmacy Value Alliance LLC 407 East Lancaster Avenue Wayne, PA 19087 785PVHemSupp.jpg Premier Value Hemorrhoidal 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 difficulty in urination due to enlargement of the prostate gland high blood pressure diabetes
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 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 at room temperature or in a cool place but not over 80°F
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-492-5988
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 exceed the recommended daily dosage unless directed by a doctor in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly
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 or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression Ask a doctor before use if you have heart disease thyroid disease difficulty in urination due to enlargement of the prostate gland high blood pressure diabetes When using this product do not exceed the recommended daily dosage unless directed by a doctor in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly 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 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