Alka-seltzer Plus Maximum Strength Cough, Mucus And Congestion Day And Night
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride
Bayer Healthcare, Llc.
Human Otc Drug
NDC 0280-0062Alka-seltzer Plus Maximum Strength Cough, Mucus And Congestion Day And Night also known as Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride is a human otc drug labeled by 'Bayer Healthcare, Llc.'. National Drug Code (NDC) number for Alka-seltzer Plus Maximum Strength Cough, Mucus And Congestion Day And Night is 0280-0062. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Alka-seltzer Plus Maximum Strength Cough, Mucus And Congestion Day And Night drug includes . The currest status of Alka-seltzer Plus Maximum Strength Cough, Mucus And Congestion Day And Night drug is Active.
Drug Information:
| Drug NDC: | 0280-0062 |
| 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 Maximum Strength Cough, Mucus And Congestion Day And Night |
| 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: | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride |
| 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: | Kit |
| 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: | |
| 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 Jun, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| 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: | 1297288
1656815
1657147
|
| 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: | 0016500584223
|
| UPC stands for Universal Product Code. |
| UNII: | |
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0280-0062-01 | 1 KIT in 1 CARTON (0280-0062-01) * 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 01 Jun, 2020 | 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 maximum strength cough, mucus and congestion day and night acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride alka-seltzer plus maximum strength cough, mucus and congestion day powermax acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride polyethylene glycol, unspecified propylene glycol sodium hydroxide guaifenesin guaifenesin gelatin medium-chain triglycerides povidone water shellac sorbitan sorbitol titanium dioxide acetaminophen acetaminophen phenylephrine hydrochloride phenylephrine dextromethorphan hydrobromide dextromethorphan fd&c red no. 40 lecithin, soybean potassium aluminum disilicate elliptical asp;s alka-seltzer plus maximum strength cough, mucus and congestion night powermax acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride dextromethorphan hydrobromide dextromethorphan d&c yellow no. 10 gelatin polyethylene glycol, unspecified sorbitol phenylephrine hydrochloride phenylephrine fd&c blue no. 1 povidone shellac sodium hydroxide sorbitan titanium dioxide propylene glycol acetaminophen acetaminophen potassium aluminum disilicate water doxylamine succinate doxylamine elliptical asp;n
Indications and Usage:
Uses uses · helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive · temporarily relieves these symptoms due to a cold or flu: · nasal congestion · sinus congestion and pressure · minor aches and pains · headache · cough · sore throat · temporarily reduces fever
Uses uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · nasal and sinus congestion · cough · sore throat · runny nose · sneezing · temporarily reduces fever
Warnings:
Warnings 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 product allergy 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 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 (
Read more...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 ask a doctor before use if you have ask a doctor before use if you have ? liver disease ? heart disease ? high blood pressure ? thyroid disease ? diabetes ? difficulty in urination due to enlargement of the prostate gland ? persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ? cough with excessive phlegm (mucus) when using this product when using this product do not exceed recommended dosage ask a doctor or pharmacist before use if you are ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin stop use and ask a doctor if stop use and ask a doctor if · 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 · cough comes back or occurs with fever, rash or headache that lasts. these could be signs of a serious condition. · nervousness, dizziness, or sleeplessness occurs if pregnant or breast-feeding if pregnant or breast-feeding, ask a health professional before use. 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.
Warnings 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 product allergy 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. do not use 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 prescriptio
Read more...n 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 ask a doctor before use if you have ask a doctor before use if you have ? liver disease ? heart disease ? high blood pressure ? thyroid disease ? diabetes ? glaucoma ? cough with excessive phlegm (mucus) ? a breathing problem such as emphysema or chronic bronchitis ? difficulty in urination due to enlargement of the prostate gland ? persistent or chronic cough such as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are ask a doctor or pharmacist before use if you are ? taking the blood thinning drug warfarin ? taking sedatives or tranquilizers when using this product when using this product ? do not exceed recommended dosage ? may cause marked drowsiness ? avoid alcoholic drinks ? alcohol, sedatives, and tranquilizers may increase drowsiness ? be careful when driving a motor vehicle or operating machinery ? excitability may occur, especially in children stop use and ask a doctor if stop use and ask a doctor if · 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 · cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. · nervousness, dizziness, or sleeplessness occurs if pregnant or breast-feeding if pregnant or breast-feeding, ask a health professional before use. 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.
Do Not Use:
Warnings 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 product allergy 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 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 ? in children under 12 years of age ask a doctor before use if you have ask a doctor before use if you have ? liver disease ? heart disease ? high blood pressure ? thyroid disease ? diabetes ? difficulty in urination due to enlargement of the prostate gland ? persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ? cough with excessive phlegm (mucus) when using this product when using this product do not exceed recommended dosage ask a doctor or pharmacist before use if you are ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin stop use and ask a doctor if stop use and ask a doctor if · 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 · cough comes back or occurs with fever, rash or headache that lasts. these could be signs of a serious condition. · nervousness, dizziness, or sleeplessness occurs if pregnant or breast-feeding if pregnant or breast-feeding, ask a health professional before use. 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.
Warnings 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 product allergy 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. do not use 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 ? in children under 12 years of age ask a doctor before use if you have ask a doctor before use if you have ? liver disease ? heart disease ? high blood pressure ? thyroid disease ? diabetes ? glaucoma ? cough with excessive phlegm (mucus) ? a breathing problem such as emphysema or chronic bronchitis ? difficulty in urination due to enlargement of the prostate gland ? persistent or chronic cough such as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are ask a doctor or pharmacist before use if you are ? taking the blood thinning drug warfarin ? taking sedatives or tranquilizers when using this product when using this product ? do not exceed recommended dosage ? may cause marked drowsiness ? avoid alcoholic drinks ? alcohol, sedatives, and tranquilizers may increase drowsiness ? be careful when driving a motor vehicle or operating machinery ? excitability may occur, especially in children stop use and ask a doctor if stop use and ask a doctor if · 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 · cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. · nervousness, dizziness, or sleeplessness occurs if pregnant or breast-feeding if pregnant or breast-feeding, ask a health professional before use. 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.
When Using:
When using this product when using this product do not exceed recommended dosage
When using this product when using this product ? do not exceed recommended dosage ? may cause marked drowsiness ? avoid alcoholic drinks ? alcohol, sedatives, and tranquilizers may increase drowsiness ? be careful when driving a motor vehicle or operating machinery ? excitability may occur, especially in children
Dosage and Administration:
Directions directions · do not take more than the recommended dose · do not take the day and night products at the same time; wait 4 hours after the last night dose before starting day product · adults and children 12 years and over: take 2 capsules with water every 4 hours. do not exceed 6 capsules in 12 hours or as directed by a doctor. · children under 12 years: do not use
Directions directions · do not take more than the recommended dose · do not take the day and night products at the same time; wait 4 hours after the last day dose before starting night product · adults and children 12 years and over: take 2 capsules with water every 4 hours. do not exceed 4 capsules in 12 hours or as directed by a doctor. · children under 12 years: do not use
Stop Use:
Stop use and ask a doctor if stop use and ask a doctor if · 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 · cough comes back or occurs with fever, rash or headache that lasts. these could be signs of a serious condition. · nervousness, dizziness, or sleeplessness occurs
Stop use and ask a doctor if stop use and ask a doctor if · 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 · 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:
Package label new alka-seltzer plus® maximum strength cough, mucus & congestion powermax® gels concentrated formula day non drowsy acetaminophen/ pain reliever reducer dextromethorphan hbr / cough suppressant guaifenesin / expectorant phenyleprine hcl/ nasal decongestant nasal/chest congestion headache, body ache, sore throat, fever cough mucus 16 liquid gels night acetaminophen/ pain reliever reducer dextromethorphan hbr / cough suppressant doxylamine succinate/ antihistamine phenyleprine hcl/ nasal decongestant nasal/chest congestion headache, body ache, sore throat, fever runny nose, sneezing cough 8 liquid gels: 24 total carton label 24 count
Further Questions:
Questions or comments questions or comments? 1-800-986-0369 (mon-fri 9am - 5pm est)
Questions or comments questions or comments? 1-800-986-0369 (mon-fri 9am - 5pm est)