NDC 58407-010 Stahist Tp

Phenylephrine Hcl And Triprolidine Hcl

NDC Product Code 58407-010

NDC CODE: 58407-010

Proprietary Name: Stahist Tp 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: Phenylephrine Hcl And Triprolidine Hcl 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):
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
11 MM
Imprint(s):
T;P
Score: 2

NDC Code Structure

  • 58407 - Magna Pharmaceuticals, Inc.

NDC 58407-010-10

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Stahist Tp with NDC 58407-010 is a a human over the counter drug product labeled by Magna Pharmaceuticals, Inc.. The generic name of Stahist Tp is phenylephrine hcl and triprolidine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Magna 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.

Stahist Tp 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.

  • TRIPROLIDINE HYDROCHLORIDE 2.5 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 10 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)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

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: Magna Pharmaceuticals, Inc.
Labeler Code: 58407
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: 05-25-2020 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.

Stahist Tp Product Label Images

Stahist Tp 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

Other

Drug Facts

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, watery eyesnasal congestionreduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do Not Use This Product

  • If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains 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 bronchitisglaucomaheart diseasehigh blood pressurethyroid diseasediabetes melitusdifficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor before use if you are taking sedatives or tranquilizers

When Using This Product

  • Excitability may occur, especially in childrenmay cause drowsinessalcohol, sedatives and tranquilizers may increase drowsiness effectavoid alcoholic beveragesuse caution when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • Nervousness, dizziness or sleeplessness occurcough or nasal congestion persists for more than
  • 1 week, tends to recur or is accompanied by a fever, rash
  • Or persistent headache. These could be signs of a serious
  • Condition.
  • New symptoms occur

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Purpose

Nasal DecongestantAntihistamine

Active Ingredients

(in each tablet)

Phenylephrine HCl 10 mg ..................... Nasal Decongestant

Triprolidine HCl 2.5 mg .................................. Antihistamine

Directions

Do not exceed recommended dosage.Adults and children 12 years of age and over:1 tablet by mouth every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctorChildren 6 to under 12 years of age:½ tablet by mouth every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctorChildren under 6 years of ageConsult a doctor

Inactive Ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Other Information

Store at 15°-30° C (59°-86° F)

Tamper evident by foil seal under cap. Do not use if foil seal is

missing or broken.
Rev. 2/20

* Please review the disclaimer below.