NDC 80070-600 Primatene

Ephedrine Hydrochloride

NDC Product Code 80070-600

NDC CODE: 80070-600

Proprietary Name: Primatene 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: Ephedrine 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):
YELLOW (C48330 - LIGHT YELLOW COLOR)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
PT;IN;CIRCLE;ENGRAVED
Score: 1

NDC Code Structure

NDC 80070-600-24

Package Description: 2 BLISTER PACK in 1 CARTON > 12 TABLET in 1 BLISTER PACK

NDC 80070-600-60

Package Description: 5 BLISTER PACK in 1 CARTON > 12 TABLET in 1 BLISTER PACK

NDC Product Information

Primatene with NDC 80070-600 is a a human over the counter drug product labeled by Foundation Consumer Brands. The generic name of Primatene is ephedrine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Foundation Consumer Brands

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.

Primatene 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.

  • EPHEDRINE HYDROCHLORIDE 12.5 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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.

Product Labeler Information

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

Labeler Name: Foundation Consumer Brands
Labeler Code: 80070
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: 01-22-2021 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: 12-31-2022 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.

Primatene Product Label Images

Primatene 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

Distributed by:Foundation Consumer Brands, LLCPittsburgh, PA 15212

Active Ingredient (In Each Tablet)

Ephedrine HCl 12.5 mg

Purpose

Bronchodilator

Use

  • For temporary relief of mild symptoms of intermittent asthma: wheezingtightness of chestshortness of breath

Asthma Alert

  • Because asthma may be life threatening, see a doctor if youare not better in 60 minutesget worseneed more than 12 tablets in 24 hoursuse more than 8 tablets in 24 hours for 3 or more days a weekhave more than 2 asthma attacks in a weekThese may be signs that your asthma is getting worse.This product will not give you asthma relief as quickly as an inhaled bronchodilator.

Otc - Do Not Use

  • Do not useunless a doctor said you have asthmaif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken 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.if you have ever had an allergic reaction to this product or any of its ingredients

Otc - Ask Doctor

  • Ask a doctor before use if you haveever been hospitalized for asthmaheart diseasehigh blood pressurediabetesthyroid diseaseseizuresnarrow angle glaucomaa psychiatric or emotional conditiontrouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you aretaking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditionstaking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)

Otc - When Using

  • When using this productyour blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.your risk of heart attack or stroke increases if you:have a history of high blood pressure or heart diseasetake this product more frequently or take more than the recommended doseavoid foods or beverages that contain caffeineavoid dietary supplements containing ingredients reported or claimed to have a stimulant effect

Otc - Stop Use

  • Stop use and ask a doctor ifyour asthma is getting worse (see Asthma alert)you have difficulty sleepingyou have a rapid heart beatyou have tremors, nervousness, or seizure

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

Directions

  • Do not take more than directedadults and children 12 years and over: take 1-2 tablets every 4 hours as needed. Do not take more than 12 tablets in 24 hours.children under 12 years of age: do not use

Other Information

  • Store at 20-25°C (68-77°F)

Inactive Ingredients

D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, stearic acid

* Please review the disclaimer below.