Alka-seltzer Plus Severe Cold Powerfast Fizz Non Drowsy
Asprin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate
Bayer Healthcare Llc.
Human Otc Drug
NDC 0280-0024Alka-seltzer Plus Severe Cold Powerfast Fizz Non Drowsy also known as Asprin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate is a human otc drug labeled by 'Bayer Healthcare Llc.'. National Drug Code (NDC) number for Alka-seltzer Plus Severe Cold Powerfast Fizz Non Drowsy is 0280-0024. This drug is available in dosage form of Tablet, Effervescent. The names of the active, medicinal ingredients in Alka-seltzer Plus Severe Cold Powerfast Fizz Non Drowsy drug includes Aspirin - 325 mg/1 Dextromethorphan Hydrobromide - 10 mg/1 Phenylephrine Bitartrate - 7.8 mg/1 . The currest status of Alka-seltzer Plus Severe Cold Powerfast Fizz Non Drowsy drug is Active.
Drug Information:
| Drug NDC: | 0280-0024 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Alka-seltzer Plus Severe Cold Powerfast Fizz Non Drowsy |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Asprin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bayer Healthcare Llc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Effervescent |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ASPIRIN - 325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE - 10 mg/1
PHENYLEPHRINE BITARTRATE - 7.8 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Apr, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part341 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Bayer HealthCare LLC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1536498
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0016500590965
|
| UPC stands for Universal Product Code. |
| NUI: | N0000000160
N0000008836
M0001335
N0000175722
N0000175578
N0000008832
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | R16CO5Y76E
9D2RTI9KYH
27O3Q5ML57
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Cyclooxygenase Inhibitors [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Nonsteroidal Anti-inflammatory Drug [EPC]
Platelet Aggregation Inhibitor [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Decreased Prostaglandin Production [PE]
Decreased Platelet Aggregation [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Anti-Inflammatory Agents, Non-Steroidal [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Adrenergic alpha1-Agonists [MoA]
Anti-Inflammatory Agents
Non-Steroidal [CS]
Cyclooxygenase Inhibitors [MoA]
Decreased Platelet Aggregation [PE]
Decreased Prostaglandin Production [PE]
Nonsteroidal Anti-inflammatory Drug [EPC]
Platelet Aggregation Inhibitor [EPC]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
alpha-1 Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0280-0024-01 | 10 POUCH in 1 CARTON (0280-0024-01) / 2 TABLET, EFFERVESCENT in 1 POUCH | 30 Apr, 2020 | N/A | No |
| 0280-0024-02 | 24 POUCH in 1 CARTON (0280-0024-02) / 2 TABLET, EFFERVESCENT in 1 POUCH | 01 Jul, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Product Elements:
Alka-seltzer plus severe cold powerfast fizz non drowsy asprin, dextromethorphan hydrobromide, phenylephrine bitartrate mannitol sodium bicarbonate aspirin aspirin phenylephrine bitartrate phenylephrine calcium silicate dimethicone fd&c red no. 40 anhydrous citric acid dextromethorphan hydrobromide dextromethorphan fd&c yellow no. 6 povidone, unspecified sucralose potassium bicarbonate asp speckled
Indications and Usage:
Uses uses · temporarily relieves these symptoms due to a cold with cough: · minor aches and pains · headache · cough · nasal and sinus congestion · sore throat · temporarily reduces fever
Warnings:
Warnings warnings reyeâs 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 reyeâs syndrome, a rare but serious illness. allergy alert: aspirin may cause a severe allergic reaction which may include: · hives · facial swelling · asthma (wheezing) · shock stomach bleeding warning: this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if you â are age 60 or older â have had stomach ulcers or bleeding problems â take a blood thinning (anticoagulant) or steroid drug â take other drugs containing prescription or nonprescription nsaids (aspirin, ibuprofen, naproxen, or others) â have 3 or more alcoholic drinks every day while using this product â take more or for a longer time than di
Read more...rected 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 do not use â if you are allergic to aspirin or any other pain reliever/fever reducer â 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. â if you have ever had an allergic reaction to this product or any of its ingredients â in children under 12 years of age ask a doctor ask a doctor before use if â stomach bleeding warning applies to you â you have a history of stomach problems, such as heartburn â you have high blood pressure, heart disease, liver cirrhosis, or kidney disease â you are taking a diuretic â you have â asthma â thyroid disease â diabetes â cough with excessive phlegm (mucus) â difficulty in urination due to enlargement of the prostate gland â persistent or chronic cough such as occurs with smoking, asthma, or emphysema â a sodium-restricted diet ask a doctor or pharmacist ask a doctor or pharmacist before use if you are · taking a prescription drug for · gout · diabetes · arthritis when using this product when using this product do not exceed recommended dosage stop use stop use and ask a doctor if · an allergic reaction occurs. seek medical help right away. â you experience any of the following signs of stomach bleeding â feel faint â vomit blood â have bloody or black stools â have stomach pain that does not get better · pain, cough, or nasal congestion 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 · ringing in the ears or a loss of hearing occurs · cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. · nervousness, dizziness, or sleeplessness occurs pregnant 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. keep out of reach keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings warnings reyeâs 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 reyeâs syndrome, a rare but serious illness. allergy alert: aspirin may cause a severe allergic reaction which may include: · hives · facial swelling · asthma (wheezing) · shock stomach bleeding warning: this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if you â are age 60 or older â have had stomach ulcers or bleeding problems â take a blood thinning (anticoagulant) or steroid drug â take other drugs containing prescription or nonprescription nsaids (aspirin, ibuprofen, naproxen, or others) â have 3 or more alcoholic drinks every day while using this product â 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 do not use â if you are allergic to aspirin or any other pain reliever/fever reducer â 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. â if you have ever had an allergic reaction to this product or any of its ingredients â in children under 12 years of age ask a doctor ask a doctor before use if â stomach bleeding warning applies to you â you have a history of stomach problems, such as heartburn â you have high blood pressure, heart disease, liver cirrhosis, or kidney disease â you are taking a diuretic â you have â asthma â thyroid disease â diabetes â cough with excessive phlegm (mucus) â difficulty in urination due to enlargement of the prostate gland â persistent or chronic cough such as occurs with smoking, asthma, or emphysema â a sodium-restricted diet ask a doctor or pharmacist ask a doctor or pharmacist before use if you are · taking a prescription drug for · gout · diabetes · arthritis when using this product when using this product do not exceed recommended dosage stop use stop use and ask a doctor if · an allergic reaction occurs. seek medical help right away. â you experience any of the following signs of stomach bleeding â feel faint â vomit blood â have bloody or black stools â have stomach pain that does not get better · pain, cough, or nasal congestion 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 · ringing in the ears or a loss of hearing occurs · cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. · nervousness, dizziness, or sleeplessness occurs pregnant 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. keep out of reach keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
When Using:
When using this product when using this product do not exceed recommended dosage
Dosage and Administration:
Directions directions â 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. â children under 12 years: do not use
Stop Use:
Stop use stop use and ask a doctor if · an allergic reaction occurs. seek medical help right away. â you experience any of the following signs of stomach bleeding â feel faint â vomit blood â have bloody or black stools â have stomach pain that does not get better · pain, cough, or nasal congestion 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 · ringing in the ears or a loss of hearing occurs · cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. · nervousness, dizziness, or sleeplessness occurs
Package Label Principal Display Panel:
Carton 20 count alka-seltzer plus® severe cold citrus powerfast⢠fizz new improved flavor non-drowsy aspirin (nsaid) / pain reliever-fever reducer dextromehorphan hbr / cough suppressant phenylephrine bitartrate / nasal decongestant fever + body ache nasal congestion sinus pressure sore throat cough 20 effervescent tablets asp cold 1 asp cold 2
Further Questions:
Questions questions or comments? 1-800-986-0369 (mon-fri 9am â 5pm est)