NDC 0280-0035 Alka-seltzer Plus Cough, Mucus And Congestion Day And Night Powermax

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride

NDC Product Code 0280-0035

NDC CODE: 0280-0035

Proprietary Name: Alka-seltzer Plus Cough, Mucus And Congestion Day And Night Powermax 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, Guaifenesin, 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.

NDC Code Structure

  • 0280 - Bayer Healthcare Llc.
    • 0280-0035 - Alka-seltzer Plus Cough, Mucus And Congestion Day And Night Powermax

NDC 0280-0035-01

Package Description: 1 KIT in 1 CARTON * 3 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 3 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Alka-seltzer Plus Cough, Mucus And Congestion Day And Night Powermax with NDC 0280-0035 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Alka-seltzer Plus Cough, Mucus And Congestion Day And Night Powermax is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride. The product's dosage form is kit and is administered via oral form.

Labeler Name: Bayer Healthcare Llc.

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • POVIDONE (UNII: FZ989GH94E)
  • SHELLAC (UNII: 46N107B71O)
  • SORBITAN (UNII: 6O92ICV9RU)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POVIDONE (UNII: FZ989GH94E)
  • GELATIN (UNII: 2G86QN327L)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • SHELLAC (UNII: 46N107B71O)

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.
  • 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: 06-01-2020 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: 12-31-2021 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.

Alka-seltzer Plus Cough, Mucus And Congestion Day And Night Powermax Product Label Images

Alka-seltzer Plus Cough, Mucus And Congestion Day And Night Powermax 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

Product Name

Do not take these products at the same time.Alka-Seltzer Plus® Maximum Strength Cough, Mucus & Congestion Day PowerMax® Gels

Alka-Seltzer Plus® Maximum Strength Cough, Mucus & Congestion Night PowerMax® Gels

Active Ingredients And Purpose

Active ingredients (in each capsule) PurposesAcetaminophen 325 mg…………….……….Pain reliever/fever reducerDextromethorphan hydrobromide 10 mg…………..Cough suppressantGuaifenesin 200 mg…………………………………………..ExpectorantPhenylephrine hydrochloride 5 mg………………...Nasal decongestant

Active ingredients (in each capsule) PurposesAcetaminophen 325 mg…………….… ……...Pain reliever/fever reducerDextromethorphan hydrobromide 10 mg…… ………Cough suppressantDoxylamine succinate 6.25 mg…………… ………………...AntihistaminePhenylephrine hydrochloride 5 mg.....…… ………...Nasal decongestant

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 · 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

WarningsLiver 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.

WarningsLiver 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 medicalhelp 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

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)

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

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 productdo not exceed recommended dosage

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 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· 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.

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.

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.

Directions

Directions· do not take more than the recommended dose· do not take the Day and Night products at the same time; wait 4 hoursafter the last Night dose before starting Day product· adults and children 12 years and over: take 2 capsules with waterevery 4 hours. Do not exceed 6 capsules in 12 hours or asdirected by a doctor.· children under 12 years: do not use

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

Other Information

Other information · store at 15°- 25°C (59° - 77°F)

Other information· store at 15° - 25°C (59° - 77°F)

Inactive Ingredients

Inactive ingredients FD&C red No. 40, gelatin, glycerin, lecithin, medium chain triglycerides, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Inactive ingredients D&C yellow No. 10, FD&C blue No. 1, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Product Carton Label 24 Count

  • NEWAlka-SeltzerPLUSMAXIMUMSTRENGTHCough,Mucus &CongestionPOWERMAX® GELSCONCENTRATED FORMULADAY NON DROWSYACETAMINOPHEN / Pain Reliever-Fever ReducerDextromethorphan HBr / Cough SuppressantGuaifenesin / ExpectorantPhenylephrine HCl / Nasal DecongestantNasal/Chest CongestionHeadache, Body Ache Sore Thoat, FeverCoughMucus16 LIQUID GELSNIGHTACETAMINOPHEN / Pain Reliever-Fever ReducerDextromethorphan HBr / Cough SuppressantDoxylamine Succinate / AntihistaminePhenylephrine HCl / Nasal DecongestantNasal / Chest CongestionHeadache, Body Ache, Sore Throat, FeverRunny Nose, SneezingCough8 LIQUID GELS: 24 TOTAL

* Please review the disclaimer below.