NDC 13411-852 Acetaflu Cough And Chest Congestion

Dextromethorphan Hbr, Guaifenesin

  1. Labeler Index
  2. Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals
  3. NDC: 13411-852 Acetaflu Cough And Chest Congestion

NDC Product Code 13411-852

NDC CODE: 13411-852

Proprietary Name: Acetaflu Cough And Chest Congestion 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: Dextromethorphan Hbr, 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.
  • Guaifenesin is used to treat coughs and congestion 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. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. 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).

NDC Code Structure

NDC 13411-852-06

Package Description: 6 PACKET in 1 BOX > 5 g in 1 PACKET

NDC 13411-852-12

Package Description: 12 PACKET in 1 BOX > 5 g in 1 PACKET

NDC 13411-852-20

Package Description: 20 PACKET in 1 BOX > 5 g in 1 PACKET

NDC Product Information

Acetaflu Cough And Chest Congestion with NDC 13411-852 is a a human over the counter drug product labeled by Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals. The generic name of Acetaflu Cough And Chest Congestion is dextromethorphan hbr, guaifenesin. The product's dosage form is powder and is administered via oral form.

Labeler Name: Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Acetaflu Cough And Chest Congestion 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.
  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/5g
  • GUAIFENESIN 400 mg/5g

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.
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MANNITOL (UNII: 3OWL53L36A)
  • POVIDONE K30 (UNII: U725QWY32X)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SUCROSE (UNII: C151H8M554)

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: Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals
Labeler Code: 13411
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: 08-31-2020 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’.

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Acetaflu Cough And Chest Congestion Product Label Images

Acetaflu Cough And Chest Congestion 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

Dextromethorphan HBr 20 mgGuaifenesin 400 mg

Purposes

  • Cough suppressantExpectorant

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

  • Do not use in a child under 12 years of age 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 cough that occurs with too much phlegm (mucus)cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysemaa sodium-restricted dietWhen using this productdo not exceed recommended dosageStop use and ask a doctor ifcough lasts more than 7 days, comes back or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.If pregnant or breast-feeding,ask a health care 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

  • Do not use more than directed take every 4 hours. Do not take more than 6 packets in 24 hours.AgeDoseadults and children 12 years of age and over  one packet children under 12 years of agedo not use dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.if using microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Other Information

  • Each packet contains: potassium 12 mg, sodium 51 mg.store at controlled room temperature 20-25°C (68-77°F).

Inactive Ingredients.

Acesulfame potassium, anhydrous citric acid, flavor, lactose, maltodextrin, mannitol, povidone K30, silicon dioxide, sodium bicarbonate, sodium chloride, sodium citrate, sucralose, sucrose

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