NDC 53499-0232 Air Power

Guaifenesin

NDC Product Code 53499-0232

NDC CODE: 53499-0232

Proprietary Name: Air Power 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: Guaifenesin 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used for the temporary relief of coughs caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. This product (sustained-release) is not recommended for use in children younger than 12 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold. To decrease the risk for side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Product Characteristics

Color(s):
BROWN (C48332 - LIGHT BROWN TO GRAY-BROWN W/ LIGHT AND/OR DARK SPECKS)
Shape: OVAL (C48345)
Size(s):
20 MM
Imprint(s):
232

NDC Code Structure

  • 53499 - Schwabe North America, Inc

NDC 53499-0232-1

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Air Power with NDC 53499-0232 is a a human over the counter drug product labeled by Schwabe North America, Inc. The generic name of Air Power is guaifenesin. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 197741.

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.

Air Power 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.


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.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • ICODEXTRIN (UNII: 2NX48Z0A9G)
  • FENUGREEK SEED (UNII: 654825W09Z)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
  • VERBASCUM THAPSUS LEAF (UNII: ANX0EG34JE)
  • POVIDONE (UNII: FZ989GH94E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • 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: Schwabe North America, Inc
Labeler Code: 53499
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: 06-14-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Air Power 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 Ingredient:

Guaifenesin 200 mg

Inactive Ingredients:

Carnauba wax, cellulose, dextrin, fenugreek seed extract, glycerin, hypromellose, magnesium stearate, maltodextrin, marshmallow root extract, mullein leaf extract, povidone, silica, sodium croscarmellose, stearic acid.

Dosage & Administration:

Dosage:  Adults and Children 12 years and over:  1-2 tabletss every 4 hours, not to exceed 12 tablets in 24 hours.Children 6 to 11 years of age: 1/2 to 1 tablets every 4 hours not to exceed 6 tablets in 24 hours.Children under 6 years of age:  consult a doctor.

Purpose:

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of mucus and make coughs more productive.

Indications & Useage:

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of mucus and make coughs more productive.

Warnings:

Do not use this product if you are pregnant, attempting to become pregnant, or breast-feeding. Do not take this product for persistent or chronic cough such that occurs with smoking, asthma, chronic bronchitis or emphysema or where cough is accompaied by excessive phlegm (mucus) unless directed by a doctor.

Ask A Doctor Before Use If You Have:

Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, have a cough that is accompanied by excessive phlegm (mucus), have diabetes, are taking antibiotics or any other prescription medication.

Stop Use:

Stop use and ask a doctor if cough persists more than one week, tends to recur, or is accompanied by a fever, rash or persisient headache.A persistent cough may be a sign of a serious condition.If you are taking any medications, consult a consult a healthcare professional before use.

Keep Out Of Reach Of Children:

Keep out of the reach of children.

Overdosage:

In case of overdose, seek medical help or contact a Poison Control Center immediately.

* Please review the disclaimer below.