NDC 0280-0060 Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz

Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate

NDC Product Code 0280-0060

NDC CODE: 0280-0060

Proprietary Name: Alka-seltzer Plus Cold Sparkling Original 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: Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate 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):
ALKA;SELTZERPLUS
Score: 1
Flavor(s):
LEMON (C73396)

NDC Code Structure

  • 0280 - Bayer Healthcare Llc.

NDC 0280-0060-01

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

NDC 0280-0060-02

Package Description: 18 POUCH in 1 CARTON > 2 TABLET, EFFERVESCENT in 1 POUCH

NDC Product Information

Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz with NDC 0280-0060 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz is aspirin, chlorpheniramine maleate, phenylephrine bitartrate. 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: 1536840.

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 Cold Sparkling Original 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.

  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
  • POVIDONE (UNII: FZ989GH94E)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • CALCIUM SILICATE (UNII: S4255P4G5M)
  • MANNITOL (UNII: 3OWL53L36A)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)

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 Cold Sparkling Original Powerfast Fizz Product Label Images

Alka-seltzer Plus Cold Sparkling Original 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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
● are age 60 or older● have had stomach ulcers or bleeding problems● take a blood thinning (anticoagulant) or steroid drug● take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)● have 3 or more alcoholic drinks every day while using this product● take more or for a longer time than directed

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 - Active Ingredient

Active ingredients (in each tablet) PurposesAspirin 325 mg (NSAID)*…..………….……..Pain reliever/fever reducerChlorpheniramine maleate 2 mg.……………..…...…….....AntihistaminePhenylephrine bitartrate 7.8 mg …........…………...Nasal decongestant*nonsteroidal anti-inflammatory drug

Uses

  • Temporarily relieves these symptoms due to a cold:minor aches and painsheadacherunny nosenasal congestionsneezingsore throatsinus congestion and pressuretemporarily reduces fever

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy Alert

Allergy alert: Aspirin may cause a severe allergic reaction which may include:
● hives● facial swelling● asthma (wheezing) ● shock

Do Not Use

● if you are allergic to aspirin or any other pain reliever/fever reducer● 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● in children under 12 years of age

Otc - Ask Doctor

Ask a doctor before use if● stomach bleeding warning applies to you● you have a history of stomach problems, such as heartburn● you have high blood pressure, heart disease, liver cirrhosis, or kidney disease● you are taking a diuretic● you have ● asthma ● diabetes ● thyroid disease ● glaucoma ● difficulty in urination due to enlargement of the prostate gland ● a breathing problem such as emphysema or chronic bronchitis● a sodium-restricted diet

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you are
  • Taking a prescription drug forgoutdiabetesarthritistaking sedatives or tranquilizers

Otc - Stop Use

  • Ask a doctor or pharmacist before use if you are
  • Taking a prescription drug forgout diabetesarthritistaking sedatives or tranquilizers

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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.

Dosage & Administration

Directions● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.● children under 12 years: do not use

Other Safety Information

Other information

each 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, 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.