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| Product NDC Code | 0573-1378 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Preparation h |
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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 | ||||||||
| RxCUI drug identifier | 312398 | ||||||||
| Application Number | M015 | ||||||||
| Labeler Name | Haleon US Holdings 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 ingredient Phenylephrine HCl 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: 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 this product. detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows: hold suppository with the rounded end up as shown, carefully separate foil tabs by inserting tip of fingernail at end marked “peel down” slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository remove exposed suppository from the wrapper 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 Directions Opening Guide 01 Directions Opening Guide 02
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cocoa butter, 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 helps relieve the local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders
Purpose
Information about the drug product’s indications for use.Purpose Vasoconstrictor
Spl product data elements
Usually a list of ingredients in a drug product.PREPARATION H Phenylephrine hydrochloride COCOA BUTTER STARCH, CORN METHYLPARABEN PROPYLPARABEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Light yellow Bullet shaped suppository
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 PREPARATION H HEMORRHOIDAL SUPPOSITORIES Phenylephrine HCl 0.25% Prevents Further Irritation Reduces Internal Hemorrhoidal Swelling Prompt Relief from Itching & Discomfort Also for Nighttime Relief 12 SUPPOSITORIES 000079890 – Front Carton Preparation H Suppositories 12 count
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.Additional Information Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 For most recent product information, visit www.preparationh.com Trademarks are owned by or licensed to the GSK group of companies. ©2022 GSK group of companies or its licensor. Made in Germany Individually quality sealed for your protection. Do Not Use if foil imprinted “PREPARATION H” is torn or damaged.
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 high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate 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 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 20-25°C (68-77°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? Call weekdays 8 AM to 6 PM EST at 1-800-99PrepH or 1-800-997-7374
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 exceed the recommended daily dosage unless directed by a doctor
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 high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate 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 exceed the recommended daily dosage unless directed by a doctor 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 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