NDC 73097-009 Nyquil Severe Cold And Flu

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride

NDC Product Code 73097-009

NDC Code: 73097-009

Proprietary Name: Nyquil Severe Cold And Flu 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, Doxylamine Succinate, 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

GREEN (C48329)
Shape: OVAL (C48345)
1 MM
Score: 1

NDC Code Structure

  • 73097 - Savings Distributors Llc
    • 73097-009 - Nyquil Severe Cold And Flu

NDC 73097-009-02

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

NDC 73097-009-20

Package Description: 40 POUCH in 1 CARTON > 2 TABLET, COATED in 1 POUCH

NDC 73097-009-25

Package Description: 50 POUCH in 1 CARTON > 2 TABLET, COATED in 1 POUCH

NDC Product Information

Nyquil Severe Cold And Flu with NDC 73097-009 is a a human over the counter drug product labeled by Savings Distributors Llc. The generic name of Nyquil Severe Cold And Flu is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Savings Distributors Llc

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

Nyquil Severe Cold And Flu 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

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.

  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

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: 07-08-2019 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 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 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]

Doxylamine is pronounced as (dox il' a meen)
Why is doxylamine medication prescribed?
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and ot...
[Read More]

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.

Nyquil Severe Cold And Flu Product Label Images

Nyquil Severe Cold And Flu 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 (In Each Caplet)

Acetaminophen 325 mgDextromethorphan HBr 10 mgDoxylamine succinate 6.25 mgPhenylephrine HCL 5 mg


Pain reliever/fever reducerCough suppressantAntihistamineNasal decongestant


Temporarily relieves common cold/flu symptoms:• nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • cough to help you sleep • minor aches & pains • headache• fever • sore throat • runny nose & sneezing• reduces swelling of nasal passages• temporarily restores freer breathing through the nose• promotes nasal and/or sinus drainage


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 caplets in 24 hours, which is the maximum daily amount for this product• 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 • Rash
If a skin reaction occurs, stop ues and seek medical help right awaySore 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.

Ask A Doctor Before Use If You Have

• liver disease • heart disease • high blood pressure • thyroid disease• diabetes • glaucoma • cough that occurs with too much phlegm (mucus)• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema• trouble urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Ues If You Are

• taking sedatives or tranquilizers • taking the blood thinning drug warfarin

When Using This Product

do not use more than directed• excitability may occur, especially in children
​ • ​marked drowsiness may occur
• avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

• you get nervous, dizzy or sleepless • pain, nasal congestion, or cough gets worse or lasts more than 7 days• fever gets wore or lasts more than 3 days • redness or swelling is present • new symptoms occur• cough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition.

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


•take only as directed • do not exceed 8 caplets per 24 hrsadults & children 12 yrs & over 2 caplets with water every 4 hrschildren 4 to under 12 yrs ask a doctor

children under 4 yrs do not use

Other Information

• do not exceed 25ºC

Inactive Ingredients

Crospovidone, D&C Yellow No.10 Aluminum Lake, FD&C Blue No.1 Aluminum Lake, FD&C Blue No.2 Aluminum Lake,FD&C Yellow No.6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide



* Please review the disclaimer below.

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