NDC 69543-251 Virtussin Ac W/alc

Codeine Phosphate And Guaifenesin

NDC Product Code 69543-251

NDC CODE: 69543-251

Proprietary Name: Virtussin Ac W/alc 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: Codeine Phosphate And 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

  • 69543 - Virtus Pharmaceuticals Llc

NDC 69543-251-16

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Virtussin Ac W/alc with NDC 69543-251 is a a human over the counter drug product labeled by Virtus Pharmaceuticals Llc. The generic name of Virtussin Ac W/alc is codeine phosphate and guaifenesin. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Virtus Pharmaceuticals Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

DEA Schedule: Schedule V (CV) Substances What is the Drug Enforcement Administration (DEA) CV Schedule?
The controlled substances in the CV schedule have an abuse potential and dependence liability less than those listed in CIV and have an accepted medical use in the United States. Substances in schedule CV are often available without prescription, and include preparations containing limited quantities of certain narcotic drugs generally for antitussive and antidiarrheal purposes. Buprenorphine is also a CV schedule drug.

Virtussin Ac W/alc 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.

  • CODEINE PHOSPHATE 10 mg/5mL
  • GUAIFENESIN 100 mg/5mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SORBITOL (UNII: 506T60A25R)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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: Virtus Pharmaceuticals Llc
Labeler Code: 69543
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: 11-04-2019 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: 12-31-2020 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.

Virtussin Ac W/alc Product Label Images

Virtussin Ac W/alc 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

Otc - Purpose

Active ingredients(in each 5 mL = 1 tsp)PurposeCodeine phosphate, USP 10 mg Cough suppressantGuaifenesin, USP 100 mgExpectorant

Uses

  • ▪temporarily relieves:▪cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants▪your cough to help you sleep▪helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive.

Ask Your Doctor Before Use If

  • ▪you have a persistent cough, this may be a sign of a serious condition▪you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema▪you have a cough that is accompanied by excessive phlegm (mucus)▪you have chronic pulmonary disease or shortness of breath▪giving to a child who is taking other drugs

When Using This Product

  • ▪giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.▪may cause or aggravate constipation

Stop Use And Ask A Doctor If

  • ▪symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.

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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • ▪do not exceed 6 doses in 24 hours.Adults and children 12 years of age and over:2 tsp (10 mL) every 4 hours, or as directed by a doctor.Children 6 to under 12 years of age:1 tsp (5 mL) every 4 hours,or as directed by a doctor.Children under 6 years of age:Consult a doctor.

Other Information

Each tsp (5 mL) contains 4 mg sodium.Store at controlled room temperature 15° to 30°C (59° to 86° F).You may report side effects by calling Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088

Inactive Ingredients

Alcohol, caramel flavor, cherry flavor, citric acid, FD&C Red #40, glycerin, menthol flavor, purified water, sodium benzoate, sodium saccharin, sorbitol.

Other

Manufactured for:Virtus Pharmaceuticals, LLCLanghorne, PA 190471-888-848-3593Made in USARev. 07/20197300-0016

* Please review the disclaimer below.