NDC 50991-788 Alahist Pe

Dexbrompheniramine Maleate, Phenylephrine Hydrochloride

NDC Product Code 50991-788

NDC CODE: 50991-788

Proprietary Name: Alahist Pe What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dexbrompheniramine Maleate, Phenylephrine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
PURPLE (C48327)
Shape: CAPSULE (C48336)
Size(s):
11 MM
Imprint(s):
POLY;782
Score: 2

NDC Code Structure

NDC 50991-788-02

Package Description: 12 TABLET in 1 BLISTER PACK

NDC 50991-788-90

Package Description: 90 TABLET in 1 BOTTLE

NDC Product Information

Alahist Pe with NDC 50991-788 is a a human over the counter drug product labeled by Poly Pharmaceuticals, Inc.. The generic name of Alahist Pe is dexbrompheniramine maleate, phenylephrine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Poly Pharmaceuticals, Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Alahist Pe Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXBROMPHENIRAMINE MALEATE 2 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 7.5 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Poly Pharmaceuticals, Inc.
Labeler Code: 50991
FDA Application Number: part341 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 08-24-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Alahist Pe Product Label Images

Alahist Pe Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Phenylephrine Hydrochloride 7.5 mg

Purpose

Dexbrompheniramine Maleate- -Antihistamine

Phenylephrine Hydrochloride-- Nasal Decongestant

Uses

  • Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:runny nosesneezingitching of the nose or throatitchy, water eyesnasal congestionreduces swelling of nasal passages

Do Not Use This Product

If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • A breathing problem such as emphysema or chronic bronchitisglaucomatrouble urinating due to enlargement of the prostate glandheart diseasehigh blood pressurethyroid diseasediabetesAsk a doctor or pharmacist before use if you are taking
  • Sedatives or tranquilizers.

When Using This Product

  • Excitability may occur, especially in childrenmay cause drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase the drowsiness effectuse caution when driving a motor vehicle or operating machinery

Stop Use And Ask Doctor If

  • Nervousness, dizziness, or sleeplessness occursymptoms do not improve within 7 days or are accompanied by fever

If Pregnant Or Breastfeeding

Ask a health professional before use.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor.Children 6 to under 12 years of age1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor.Children under 6 years of age: Consult a doctor.

Other Information

Store at 15°-30°C (59°-86°F). Supplied in a tight,light-resistant container with a child-resistant cap. Alahist PE Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.

Inactive Ingredients

Croscarmellose sodium, D&C Red # 27 aluminum lake, FD&C Blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

Alahist Pe Label

Manufactured forPoly Pharmaceuticals

Huntsville, AL 35763

* Please review the disclaimer below.