NDC 29978-588 Aquanaz Pse

Dextromethorphan Hbr, Guafenesin, Pseudoephedrine Hcl

NDC Product Code 29978-588

NDC CODE: 29978-588

Proprietary Name: Aquanaz Pse 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, Guafenesin, Pseudoephedrine 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.

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).

Product Characteristics

Color(s):
GREEN (C48329)
Shape: OVAL (C48345)
Size(s):
17 MM
Imprint(s):
AO;PSE
Score: 1

NDC Code Structure

  • 29978 - Capital Pharmaceutical, Llc

NDC 29978-588-90

Package Description: 90 TABLET in 1 BOTTLE

NDC Product Information

Aquanaz Pse with NDC 29978-588 is a a human over the counter drug product labeled by Capital Pharmaceutical, Llc. The generic name of Aquanaz Pse is dextromethorphan hbr, guafenesin, pseudoephedrine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Capital Pharmaceutical, Llc

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.

Aquanaz Pse 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/1
  • GUAIFENESIN 375 mg/1
  • PSEUDOEPHEDRINE HYDROCHLORIDE 60 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.

  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • TALC (UNII: 7SEV7J4R1U)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)

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: Capital Pharmaceutical, Llc
Labeler Code: 29978
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: 05-01-2020 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.

Aquanaz Pse Product Label Images

Aquanaz Pse 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 20mgGuaifenesin 375mgPseudoephedrine HCl 60mg

Purpose

Cough SuppressantExpectorantNasal Decongestant

Uses

Temporarily relieves these symptoms occurring with a cold nasal decongestion:

▪ cough due to minor throat and bronchial irritation

▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Warnings

  • ▪ When using this product do not exceed recommended dosage.
  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugsfor 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.

Stop Use And Ask Doctor If

▪ symptoms do not improve

▪ new symptoms occur

▪ redness or swelling is present

▪ nervousness, dizziness, or sleeplessness occur

▪ symptoms do not improve within 7 days or are accompanied by fever

▪ cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or

persistent headache. A persistent cough may be a sign of a serious condition.

Ask Doctor Before Use If You Have

▪ heart disease

▪ high blood pressure

▪ thyroid disease

▪ diabetes

▪ difficulty in urinating due to enlargement of the prostate gland

▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or

emphysema or where cough is accompanied by excessive phlegm

Directions

Adults and children 12 years of age

and over
1 tablet every 4 hours, not to

exceed 4 tablets in 24 hours, or as

directed by a doctor.

Children 6 to under 12 years of age
1/2 tablet every 4 hours, not to

exceed 2 tablets in 24 hours, or as

directed by a doctor.
Do not exceed recommended dosage.

Pregnant Or Breast Feeding

If pregnant or breast feeding, 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. Prompt

medical attention is critical for adults as well as children even if you do not notice any signs or

symptoms

Inactive Ingredients

Carnauba Wax, FD&C Blue #1 Aluminum Lake, FD&C Yellow #5 Aluminum Lake, Magnesium

Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Polyvinyl Alcohol,

Silicon Dioxide, Talc

Other Information

  • Store at 15°-30°C (59°-86°F).Aquanaz PSE is a clear coated caplet with green core, debossed with “AQ” Bisection “PSE” onone side and smooth on the other side.Contains color additives including FD&C Yellow No. 5 (tartrazine).Supplied in a tight, light-resistant container with a child-resistant cap.Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.Store at Controlled Room Temperature 15°-30°C (59°-86°F).
  • Questions? Comments
  • Call 1(614) 638-4622

Package Label

NDC 29978-588-90
Aquanaz PSE Tablets

Triple Combination Relief:

Cough Suppressant: Dextromethorphan HBr 20 mg

Expectorant: Guaifenesin 375 mg

Nasal Decongestant: Pseudoephedrine HCI 60 mg

90 tablets

* Please review the disclaimer below.