NDC 76281-504 Tussin Cf

Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

NDC Product Code 76281-504

NDC CODE: 76281-504

Proprietary Name: Tussin Cf 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 Hydrobromide, Guaifenesin, Phenylephrine 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.

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

  • 76281 - Aptapharma Inc.

NDC 76281-504-24

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Tussin Cf with NDC 76281-504 is a a human over the counter drug product labeled by Aptapharma Inc.. The generic name of Tussin Cf is dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Aptapharma Inc.

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.

Tussin Cf 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 10 mg/5mL
  • GUAIFENESIN 100 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 5 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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MENTHOL (UNII: L7T10EIP3A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL SOLUTION (UNII: 8KW3E207O2)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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: Aptapharma Inc.
Labeler Code: 76281
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: 09-30-2020 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.

Tussin Cf 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 - Active Ingredient

Drug FactsActive ingredients(in each 5 mL tsp)Dextromethorphan HBr, USP 10 mgGuaifenesin, USP 100 mgPhenylephrine HCL, USP 5 mg

Otc - Purpose

PurposeDextromethorphan HBr USP ........Cough SuppressantGuailenesin USP ..........................ExpectorantPhenylephrine HCI, USP ...............Nasal Decongestant

Indications & Usage

  • Uses■ helps loosen phlegm (mucus) and thin bronchial   secretions to drain bronchial tubes■ temporarily relieves these symptoms occurring with   a cold:nasal congestioncough due to minor throat and bronchial irritation.

Warnings

WarningsDo not use ■ if you are now taking aprescriptionmonoamine oxidase inhibitor (MAOI) (certain drugsfor depression, psychialric or emotional conditions orParkinson's disease), or for 2 weeks aMer stoppingthe MAOI drug. If you do not know il yourprescription drug contains an MAOI, ask a doctor orpharmacist before taking this product.

Otc - Ask Doctor

Ask a doctor before use if you have■ heart disease    ■ high blood pressure■ thyroid disease ■ diabetes■ trouble urinating due to enlarged prostate gland■ cough that occurs with too much phlegm (mucus)■ cough that lasts or is chronic such as occurs withsmoking, asthma, chronic bronchitis or emphysema.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use il you aretaking any other oral nasal decongestant or stimulant.

Otc - When Using

When using this product do not use more thandirected.

Otc - Stop Use

Stop use and ask a doctor if■ you get nervous, diuy or sleepless■ symptoms do not get better within 7 days or are   accompanied by fever■ cough lasts more than 7 days, comes back or is   accompanied by fever, rash or persistent   headache. These could be signs ot aserious   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 reach of children. In case of overdose,get medical help or contact aPoison Control Centerright away.

Dosage & Administration

Directions■ do not take more than 6 doses in any 24 hour period■ this adult strength product is not intended for use inchildren under 12 years of age           AGE              DOSE Adults & children 12     years & over 2 teaspoons every 4 hours Children under 12 years 2 teaspoons every 4 hours

Other Safety Information

Other information■ Keep carton for full Direction for use■ store at 20-25ºC (68-77ºF)■ do not refrigerate■ dosage cup provided■ sodium 3 mg per teaspoonful

Inactive Ingredient

Inactive ingredientsanhydrous citric acid, FD&C red no. 40, glycerin,menthol, natural & artificial flavor, propylene glycol,purified water, sodium benzoate, sorbitol solution,sucralose

Otc - Questions

Questions? Call weekdays from 9:30 AM to 4:30PM EST at 1-877·798-5944

Product Label

AP SAFE                         NDC 76821-504-24COMPARE TO THE ACTIVE INGREDIENT IN ROBITUSSIN®PEAK COLDMULTI-SYMPTOM COLD*Adult TussinMulti-Symptom ColdDextromethorphan HBr / Guaifensesin /Phenylephrine HCLCough Supressant / Expectorant /Nasal DecongestantNon-DrowsyRelieves:• Cough• Mucus• Nasal Congestion• For Ages 12 and over4 FL OZ (118 mL)CFDO NOT USE IF PRINTED SEAL UNDERCAP IS TORN OR MISSING510134303/20*This product is not manufactured or distributedby Plizer, owner of the registered trademarkRobitussin®Manufactured by:AptaPharma Inc.,1533 Union Ave,Pennsauken, NJ 08110Ap·BX·05CartonBottleres

* Please review the disclaimer below.