NDC 0280-0061 Alka-seltzer Plus Maximum Strength Cough, Mucus And Congestion Powermax

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

NDC Product Code 0280-0061

NDC CODE: 0280-0061

Proprietary Name: Alka-seltzer Plus Maximum Strength Cough, Mucus And Congestion 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, 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Guaifenesin is used to treat coughs and congestion caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold. To decrease the risk for side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
  • This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Product Characteristics

Color(s):
RED (C48326)
Shape: OVAL (C48345)
Size(s):
20 MM
Imprint(s):
ASP;S
Score: 1

NDC Code Structure

  • 0280 - Bayer Healthcare Llc.

NDC 0280-0061-01

Package Description: 2 BLISTER PACK in 1 CARTON > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC 0280-0061-02

Package Description: 2 BLISTER PACK in 1 CARTON > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Alka-seltzer Plus Maximum Strength Cough, Mucus And Congestion Powermax with NDC 0280-0061 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Alka-seltzer Plus Maximum Strength Cough, Mucus And Congestion Powermax is acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Bayer Healthcare Llc.

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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 Cough, Mucus And Congestion Powermax 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.

  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
  • GUAIFENESIN 200 mg/1
  • ACETAMINOPHEN 325 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1

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.

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

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’.

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Alka-seltzer Plus Maximum Strength Cough, Mucus And Congestion Powermax Product Label Images

Alka-seltzer Plus Maximum Strength Cough, Mucus And Congestion 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

Active Ingredients

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

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

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 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

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 Or Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

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.

Directions

Directions· do not take more than the recommended dose· adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 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)

Inactive Ingredients

Inactive ingredientsFD&C red #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

Questions Or Commens

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

Package Label Carton 24

NEW
Alka-Seltzer
PLUS®
MAXIMUM
STRENGTH
Cough,
Mucus &CongestionPOWERMAX® GELSCONCENTRATED FORMULAACETAMINOPHEN / Pain Reliever-Fever ReducerDextromethorphan HBr / Cough SuppressantGuaifenesin / ExpectorantPhenylephrine HCl / Nasal DecongestantFor
Fast Relief of:
•Nasal/Chest Congestion

•Headache, Body Ache Sore Thoat, Fever

•Cough

•Mucus

24 LIQUID GELS (Liquid Filled Capsules)

* Please review the disclaimer below.