NDC 0280-0055 Alka-seltzer Plus Maximum Strength Sinus Congestion And Pain Powerfast Fizz

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Acetaminophen, Phenylephrine Hydrochloride

NDC Product Code 0280-0055

NDC CODE: 0280-0055

Proprietary Name: Alka-seltzer Plus Maximum Strength Sinus Congestion And Pain Powerfast Fizz 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: Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Acetaminophen, 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):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
25 MM
Imprint(s):
SINUS
Score: 1
Flavor(s):
BERRY (C73365 - RASPBERRY AND MIXED BERRY)

NDC Code Structure

  • 0280 - Bayer Healthcare Llc.
    • 0280-0055 - Alka-seltzer Plus Maximum Strength Sinus Congestion And Pain Powerfast Fizz

NDC 0280-0055-01

Package Description: 10 POUCH in 1 CARTON > 2 TABLET, EFFERVESCENT in 1 POUCH

NDC Product Information

Alka-seltzer Plus Maximum Strength Sinus Congestion And Pain Powerfast Fizz with NDC 0280-0055 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Alka-seltzer Plus Maximum Strength Sinus Congestion And Pain Powerfast Fizz is chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride. The product's dosage form is tablet, effervescent and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2557336.

Dosage Form: Tablet, Effervescent - A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration.

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.

Alka-seltzer Plus Maximum Strength Sinus Congestion And Pain Powerfast Fizz 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.


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.

  • CALCIUM SILICATE (UNII: S4255P4G5M)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
  • MANNITOL (UNII: 3OWL53L36A)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

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: Bayer Healthcare Llc.
Labeler Code: 0280
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: 06-15-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Alka-seltzer Plus Maximum Strength Sinus Congestion And Pain Powerfast Fizz Product Label Images

Alka-seltzer Plus Maximum Strength Sinus Congestion And Pain Powerfast Fizz 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredients (in each tablet) PurposesAcetaminophen 325 mg…………….………...Pain reliever/fever reducerChlorpheniramine maleate 2 mg……………………..……..AntihistamineDextromethorphan hydrobromide 10 mg……………Cough suppressantPhenylephrine hydrochloride 5 mg………………….Nasal decongestant

Uses

  • Temporarily relieves these symptoms due to a cold or flu:minor aches and painsheadachecoughsore throatrunny nosesneezingnasal congestion · sinustemporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. 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 or severe
allergic reactions. Symptoms may include:· skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic 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 to sedate children.

Otc - Do Not Use

  • Do not usewith 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 emotionalconditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drugcontains an MAOI, ask a doctor or pharmacist before taking this productif you have ever had an allergic reaction to this product or any of its ingredientsin children under 12 years of age

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarintaking sedatives or tranquilizers

Otc - When Using

  • When using this productdo not exceed recommended dosagemay cause marked drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children

Otc - Stop Use

  • Stop use and ask a doctor ifpain, cough, or nasal congestion gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back or occurs with rash or headache that lasts. Thesecould be signs of a serious condition.nervousness, dizziness, or sleeplessness occurs

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 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.

Dosage & Administration

  • Directionsdo not take more than the recommended doseadults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 10 tablets in 24 hours or as directed by a doctor.children under 12 years: do not use

Other Safety Information

Other informationeach tablet contains: potassium 78 mg; sodium 356 mg
store at room temperature. Avoid excessive heat.

Inactive Ingredient

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Otc - Questions

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

* Please review the disclaimer below.