aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate

FDA Drug Profile — Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night, Alka-Seltzer Plus Severe Cold Night PowerFast Fizz, Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz

Drug Details

Generic Name
aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate
Brand Names
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night, Alka-Seltzer Plus Severe Cold Night PowerFast Fizz, Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz
Application Number
M012
Sponsor
Bayer HealthCare LLC.
NDC Codes
4
Dosage Forms
KIT, TABLET, EFFERVESCENT
Routes
ORAL
Active Ingredients
ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE

Indications and Usage

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

Warnings

Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: · hives · facial swelling · asthma (wheezing) · shock Stomach 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 directed 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 ● 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, 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 itsingredients ● in children under 12 years of age 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 kidney disease you are taking a diuretic you have asthma •thyroid •disease diabetes cough that occurs 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 or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis When using this product do not exceed recommended dosage. 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 If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert : Aspirin may cause a severe allergic reaction which may include: hives facial swelling · asthma (wheezing) shock Stomach 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 artake 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 directed 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 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, 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 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 kidney disease you are taking a diuretic you have asthma diabetes thyroid disease glaucoma cough that occurs 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 Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis taking sedatives or tranquilizers 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 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.