NDC 0280-0040 Alka-seltzer Plus Maximum Strength Day And Night Cold And Flu

Dextromethorphan Hydrobromide, Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate

NDC Product Code 0280-0040

NDC CODE: 0280-0040

Proprietary Name: Alka-seltzer Plus Maximum Strength Day And Night Cold And Flu 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: Dextromethorphan Hydrobromide, Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate 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.
    • 0280-0040 - Alka-seltzer Plus Maximum Strength Day And Night Cold And Flu

NDC 0280-0040-01

Package Description: 1 KIT in 1 CARTON * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Alka-seltzer Plus Maximum Strength Day And Night Cold And Flu with NDC 0280-0040 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Alka-seltzer Plus Maximum Strength Day And Night Cold And Flu is dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride, doxylamine succinate. 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POVIDONE (UNII: FZ989GH94E)
  • SORBITAN (UNII: 6O92ICV9RU)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • GELATIN (UNII: 2G86QN327L)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SHELLAC (UNII: 46N107B71O)
  • SORBITOL (UNII: 506T60A25R)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: 10-26-2020 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 Maximum Strength Day And Night Cold And Flu Product Label Images

Alka-seltzer Plus Maximum Strength Day And Night Cold And Flu 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

Alka-Seltzer PlusMaximum Strength Day & Night Cold & Flu Liquid Gels

Alka-Seltzer Plus® Maximum Strength Night Cold & Flu Liquid Gels

Otc - Active Ingredient

Active ingredients (in each capsule) PurposesAcetaminophen 325 mg…………….……….Pain reliever/fever reducerDextromethorphan hydrobromide 10 mg…………..Cough suppressantPhenylephrine 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

Indications & Usage

Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · cough · sore throat · nasal and sinus congestion · 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) · shockIf 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 than2 days, is accompanied or followed by fever, headache, rash, nausea,or vomiting, consult a doctor promptly.Do not use to sedate children.

Otc - 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

Otc - Ask Doctor

Ask a doctor before use if you have● liver disease ● heart disease ● high blood pressure● thyroid disease ● diabetes● cough with excessive phlegm (mucus)● 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 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

Otc - When Using

When using this product do not exceed recommended dosage.

Otc - Stop Use

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

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

Otc - Pregnancy 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.

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. 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.

Dosage & Administration

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 Safety Information

Other information● store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive Ingredient

Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Inactive ingredients D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Otc - Questions

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

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

Otc - Ask Doctor/Pharmacist

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

Directions

Directions· do not take more than the recommended dose· adults and children 12 years and over: take 2 capsules with waterevery 4 hours. Do not exceed 10 capsules in 24 hours or asdirected by a doctor.· children under 12 years: do not use

Other Information

Other information● store at room temperature. Avoid excessive heat above 40°C(104°F).

* Please review the disclaimer below.