NDC 0280-1550 Alka-seltzer Plus Cold Day And Night

Aspirin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate, Doxylamine Succinate

NDC Product Code 0280-1550

NDC CODE: 0280-1550

Proprietary Name: Alka-seltzer Plus Cold Day And Night 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: Aspirin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate, 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
25 MM
Imprint(s):
ASP;DAY
ASP;NT
Score: 1
Flavor(s):
CITRUS (C73378)
LEMON (C73396)

NDC Code Structure

  • 0280 - Bayer Healthcare Llc.
    • 0280-1550 - Alka-seltzer Plus Cold Day And Night

NDC 0280-1550-20

Package Description: 1 KIT in 1 CARTON * 6 POUCH in 1 CARTON > 2 TABLET, EFFERVESCENT in 1 POUCH * 4 POUCH in 1 CARTON > 2 TABLET, EFFERVESCENT in 1 POUCH

NDC Product Information

Alka-seltzer Plus Cold Day And Night with NDC 0280-1550 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Alka-seltzer Plus Cold Day And Night is aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate. The product's dosage form is kit and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1536498, 1536503 and 1730187.

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.

  • CALCIUM SILICATE (UNII: S4255P4G5M)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • DOCUSATE SODIUM (UNII: F05Q2T2JA0)
  • MANNITOL (UNII: 3OWL53L36A)
  • POVIDONE (UNII: FZ989GH94E)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • ASPARTAME (UNII: Z0H242BBR1)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • DOCUSATE SODIUM (UNII: F05Q2T2JA0)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • MANNITOL (UNII: 3OWL53L36A)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ASPARTAME (UNII: Z0H242BBR1)
  • CALCIUM SILICATE (UNII: S4255P4G5M)

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.

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: 09-14-2018 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Aspirin

Aspirin is pronounced as (as' pir in)

Why is aspirin medication prescribed?
Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused ...
[Read More]
Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Doxylamine

Doxylamine is pronounced as (dox il' a meen)
Why is doxylamine medication prescribed?
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and ot...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Alka-seltzer Plus Cold Day And Night 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

Alka-Seltzer Plus® Cold Day Effervescent Tablets

Drug Facts

Alka-Seltzer Plus® Cold Night Effervescent Tablets

SPL

Otc - Active Ingredient

Active ingredients (in each tablet)Aspirin 325 mg (NSAID)*Dextromethorphan hydrobromide 10 mgPhenylephrine bitartrate 7.8 mg*nonsteroidal anti-inflammatory drug

Active ingredients (in each tablet)Aspirin 500 mg (NSAID)*Dextromethorphan hydrobromide 10 mgDoxylamine succinate 6.25 mgPhenylephrine bitartrate 7.8 mg*nonsteroidal anti-inflammatory drug

Otc - Purpose

PurposesPain reliever/fever reducerCough suppressantNasal decongestant

PurposesPain reliever/fever reducerCough suppressantAntihistamineNasal decongestant

Indications & Usage

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

WarningsReye’s syndrome: Children and teenagers who have or are recovering from
chicken pox or flu-like symptoms should not use this product. When using thisproduct, if changes in behavior with nausea and vomiting occur, consult adoctor because these symptoms could be an early sign of Reye’s syndrome, arare but serious illness.Allergy alert: Aspirin may cause a severe allergic reaction which may include:
 ● hives  ● facial swelling  ● asthma (wheezing)  ● shockStomach bleeding warning: This product contains an NSAID, which may
cause severe stomach bleeding. The chance is higher if you● are age 60 or older● have had stomach ulcers or bleeding problems● take a blood thinning (anticoagulant) or steroid drug● take other drugs containing prescription or nonprescription NSAIDs(aspirin, ibuprofen, naproxen, or others)● have 3 or more alcoholic drinks every day while using this product● take more or for a longer time than directedSore 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.

WarningsReye’s syndrome: Children and teenagers who have or are recovering
from chicken pox or flu-like symptoms should not use this product. Whenusing this product, if changes in behavior with nausea and vomiting occur,consult a doctor because these symptoms could be an early sign of Reye’ssyndrome, a rare but serious illness.Allergy alert: Aspirin may cause a severe allergic reaction which may
include: ● hives  ● facial swelling  ● asthma (wheezing)  ● shockStomach bleeding warning: This product contains an NSAID, which may
cause severe stomach bleeding. The chance is higher if you● are age 60 or older● have had stomach ulcers or bleeding problems● take a blood thinning (anticoagulant) or steroid drug● take other drugs containing prescription or nonprescription NSAIDs(aspirin, ibuprofen, naproxen, or others)● have 3 or more alcoholic drinks every day while using this product● take more or for a longer time than directedSore 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● if you are allergic to aspirin or any other pain reliever/fever reducer● if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric, or emotional conditions, orParkinson's disease), or for 2 weeks after stopping the MAOI drug. If youdo not know if your prescription drug contains an MAOI, ask a doctor orpharmacist before taking this product.● if you have ever had an allergic reaction to this product or any of itsingredients● in children under 12 years of age

Do not use● if you are allergic to aspirin or any other pain reliever/fever reducer● if you are now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson's disease), or for 2 weeks after stoppingthe MAOI drug. If you do not know if your prescription drug containsan MAOI, ask a doctor or pharmacist before taking this product.● if you have ever had an allergic reaction to this product or any of itsingredients● in children under 12 years of age

Otc - Ask Doctor

Ask a doctor before use if● stomach bleeding warning applies to you● you have a history of stomach problems, such as heartburn● you have high blood pressure, heart disease, liver cirrhosis, or kidneydisease● you are taking a diuretic● you have● asthma ● 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● a sodium-restricted diet

Ask a doctor before use if● stomach bleeding warning applies to you● you have a history of stomach problems, such as heartburn● you have high blood pressure, heart disease, liver cirrhosis, orkidney disease● you are taking a diuretic● you have● asthma ● diabetes ● thyroid disease ● 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● a sodium-restricted diet

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are● taking a prescription drug for ● gout  ● diabetes  ● arthritis

Ask a doctor or pharmacist before use if you are taking a prescription drug for • gout  • diabetes  • arthritis • taking sedatives or tranquilizers

Otc - When Using

When using this product do 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

Otc - Stop Use

Stop use and ask a doctor if● an allergic reaction occurs. Seek medical help right away.
● you experience any of the following signs of stomach bleeding● feel faint ● vomit blood ● have bloody or black stools● 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 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

Stop use and ask a doctor if● an allergic reaction occurs. Seek medical help right away.● you experience any of the following signs of stomach bleeding● feel faint ● vomit blood ● have bloody or black stools● 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 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

Otc - Pregnancy 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 3months of pregnancy unless definitely directed to do so by adoctor because it may cause problems in the unborn child orcomplications during delivery.

If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin during the last 3months of pregnancy unless definitely directed to do so by adoctor because it may cause problems in the unborn child orcomplications during delivery.

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.

Keep out of reach of children. In case of overdose, get medical help
or contact a Poison Control Center right away.

Directions

Directions● 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.● children under 12 years: do not use

Directions● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not exceed 8 tablets in 24 hours or as directed by a doctor.● children under 12 years: do not use

Other Information

Other information●
each tablet contains: sodium 416 mg
● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet● store at room temperature. Avoid excessive heat

Other information● each tablet contains: sodium 476 mg● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet● store at room temperature. Avoid excessive heat.

Inactive Ingredient

Inactive ingredients acesulfame potassium, anhydrous citric
acid, aspartame, calcium silicate, dimethicone, docusate sodium,flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Inactive ingredients acesulfame potassium, anhydrous citric
acid, aspartame, calcium silicate, dimethicone, docusate sodium,flavors (natural & artificial), mannitol, povidone, sodium benzoate,sodium bicarbonate

Otc - Questions

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

Uses

Uses • temporarily relieves these symptoms due to a cold: • minor aches and pains  • headache  • runny nose • sinus congestion and pressure  • cough  • sneezing • sore throat  • nasal congestion • temporarily reduces fever

Package Display Label

  • Alka-SeltzerPLUS®DAY NON-DROWSYASPIRIN
  • (NSAID) / Pain Reliever-Fever Reducer
  • Dextromethorphan HBr / Cough SuppressantPhenylephrine Bitartrate / Nasal DecongestantNasal CongestionHeadache & Body AcheCoughSore ThroatSinus Pressure12 EFFERVESCENT TABLETSNIGHTASPIRIN (NSAID) / Pain Reliever-Fever Reducer
  • Dextromethorphan HBr / Cough SuppressantDoxylamine Succinate / AntihistaminePhenylephrine Bitartrate / Nasal DecongestantNasal CongestionHeadache & Body AcheCoughRunny noseSore Throat8 EFFERVESCENT TABLETS

* Please review the disclaimer below.