NDC 73097-011 Tylenol Cold Plus Flu Severe

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

NDC Product Code 73097-011

NDC Code: 73097-011

Proprietary Name: Tylenol Cold Plus Flu Severe 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: Acetaminophen, 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.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: OVAL (C48345)
Size(s):
19 MM
Imprint(s):
TYLENOL;SEVERE
Score: 1

NDC Code Structure

  • 73097 - Savings Distributors Llc
    • 73097-011 - Tylenol Cold Plus Flu Severe

NDC 73097-011-02

Package Description: 2 TABLET, FILM COATED in 1 POUCH

NDC 73097-011-40

Package Description: 20 POUCH in 1 CARTON > 2 TABLET, FILM COATED in 1 POUCH

NDC 73097-011-50

Package Description: 25 POUCH in 1 CARTON > 2 TABLET, FILM COATED in 1 POUCH

NDC Product Information

Tylenol Cold Plus Flu Severe with NDC 73097-011 is a a human over the counter drug product labeled by Savings Distributors Llc. The generic name of Tylenol Cold Plus Flu Severe is acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Savings Distributors Llc

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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.

Tylenol Cold Plus Flu Severe 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.

  • ACETAMINOPHEN 325 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
  • GUAIFENESIN 200 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 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.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT)

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: Savings Distributors Llc
Labeler Code: 73097
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: 07-15-2019 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.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)
Why is guaifenesin medication prescribed?
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a cla...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Tylenol Cold Plus Flu Severe Product Label Images

Tylenol Cold Plus Flu Severe 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 (In Each Caplet)

Acetaminophen 325 mgDextromethorphan HBr 10 mgGuaifenesin 200 mgPhenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducerCough suppressantExpectorantNasal decongestant

Uses

■ for the temporary relief of the following cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ cough■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive■ temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours■ with other drugs containing acetaminophen■ 3 or more alcoholic drinks every day while using this productAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rashIf a skin reaction occurs, stop use and seek medical help right away.Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.■ 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.■ if you have ever had an allergic reaction to this product or any of its ingredients.

Ask A Doctor Before Use If You Have

■ liver disease ■ heart disease■ high blood pressure ■ thyroid disease ■ diabetes■ trouble urinating due to an enlarged prostate gland■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema■ cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

Taking the blood thinning drug warfarin

When Using This Product

Do not exceed recommended dose

Stop Use And Ask A Doctor If

■ nervousness, dizziness, or sleeplessness occur■ pain, nasal congestion or cough gets worse or lasts more than 7 days■ fever gets worse or lasts more than 3 days■ redness or swelling is present■ new symptoms occur■ cough comes back or occurs with rash or headache that lastsThese could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

■ do not take more than directed (see overdose warning)
adults and children 12 years
and over ■ take 2 caplets every 4 hours ■ swallow whole; do not crush, chew or dissolve

■ do not take more than 10 caplets in 24 hours
children under 12 years ask a doctor

Other Information

■ each caplet contains: sodium 3 mg
■ store between 20-25°C (68-77°F)■ do not use if pouch is torn or damaged

Inactive Ingredients

Carnauba wax, croscarmellose sodium, D&C yellow no. 10 aluminum lake, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sucralose, titanium dioxide

* Please review the disclaimer below.

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