Preparation H
Phenylephrine Hydrochloride
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0573-1378Preparation H also known as Phenylephrine Hydrochloride is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Preparation H is 0573-1378. This drug is available in dosage form of Suppository. The names of the active, medicinal ingredients in Preparation H drug includes Phenylephrine Hydrochloride - 6.25 mg/1 . The currest status of Preparation H drug is Active.
Drug Information:
| Drug NDC: | 0573-1378 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Preparation H |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Phenylephrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suppository |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | PHENYLEPHRINE HYDROCHLORIDE - 6.25 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RECTAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 16 Dec, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part346 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312398
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 04JA59TNSJ
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Adrenergic alpha1-Agonists [MoA]
alpha-1 Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0573-1378-00 | 48 BLISTER PACK in 1 CARTON (0573-1378-00) / 1 SUPPOSITORY in 1 BLISTER PACK | 16 Dec, 2022 | N/A | No |
| 0573-1378-01 | 12 BLISTER PACK in 1 CARTON (0573-1378-01) / 1 SUPPOSITORY in 1 BLISTER PACK | 16 Dec, 2022 | N/A | No |
| 0573-1378-06 | 24 BLISTER PACK in 1 CARTON (0573-1378-06) / 1 SUPPOSITORY in 1 BLISTER PACK | 16 Dec, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose vasoconstrictor
Product Elements:
Preparation h phenylephrine hydrochloride phenylephrine hydrochloride phenylephrine cocoa butter starch, corn methylparaben propylparaben light yellow bullet shaped suppository
Indications and Usage:
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
Warnings:
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.
When Using:
When using this product do not exceed the recommended daily dosage unless directed by a doctor
Dosage and Administration:
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
Stop Use:
Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days
Package Label Principal Display Panel:
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
Further Questions:
Questions or comments? call weekdays 8 am to 6 pm est at 1-800-99preph or 1-800-997-7374