Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night Effervescent Tablets Ui 1614460 & 161897
c2232241-6e57-1427-e053-2995a90a488a
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets
Medication Information
Warnings and Precautions
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.
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
Dosage and Administration
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 taking the last Night dose before taking the Day product
- adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
- children under 12 years: do not use
Description
Drug Facts Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets
Section 42229-5
Drug Facts
Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9
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
Section 50567-7
When using this product do not exceed recommended dosage.
Section 50568-5
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for
- gout
- diabetes
- arthritis
Section 50569-3
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
Section 50570-1
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
Section 51727-6
Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose
Section 51945-4
Alka-Seltzer Plus®
SEVERE COLD
DAY/CITRUS
NIGHT LEMON
POWERFAST FIZZ™
DAY NON-DROWSY
ASPIRIN (NSAID)/Pain Reliever - Fever Reducer
DEXTROMETHORPHAN HBr/Cough Suppressant
PHENYLEPHRINE BITARTRATE/Nasal Decongestant
- Nasal Decongestant
- Headache + Body Ache
- Cough
- Sore Throat
- Sinus Pressure
12 EFFERVESCENT TABLETS
NEW NIGHT DOSING DIRECTIONS
NIGHT
Aspirin (NSAID)/Pain Reliever-Fever Reducer
Dextromethorphan HBr/Cough Suppressant
Doxylamine Succinate/Antihistamine
Phenylephrine Bitartrate/Nasal Decongestant
- Nasal congestion
- Headache + Body Ache
- Cough
- Runny Nose
- Sore Throat
8 EFFERVESCENT TABLETS
Section 53413-1
Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Section 55106-9
Active ingredients (in each tablet) Purposes
Aspirin 325 mg (NSAID)*…….………………………..Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg……………………Cough suppressant
Phenylephrine bitartrate 7.8 mg.......……....…....…………..Nasal decongestant
*nonsteroidal anti-inflammatory drug
Section 60561-8
Other information
- each tablet contains: potassium 78 mg; sodium 356 mg
- store at room temperature. Avoid excessive heat.
Structured Label Content
Indications and Usage (34067-9)
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
Dosage and Administration (34068-7)
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 taking the last Night dose before taking the Day product
- adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
- children under 12 years: do not use
Warnings and Precautions (34071-1)
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.
Section 42229-5 (42229-5)
Drug Facts
Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
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
Section 50567-7 (50567-7)
When using this product do not exceed recommended dosage.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for
- gout
- diabetes
- arthritis
Section 50569-3 (50569-3)
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
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose
Section 51945-4 (51945-4)
Alka-Seltzer Plus®
SEVERE COLD
DAY/CITRUS
NIGHT LEMON
POWERFAST FIZZ™
DAY NON-DROWSY
ASPIRIN (NSAID)/Pain Reliever - Fever Reducer
DEXTROMETHORPHAN HBr/Cough Suppressant
PHENYLEPHRINE BITARTRATE/Nasal Decongestant
- Nasal Decongestant
- Headache + Body Ache
- Cough
- Sore Throat
- Sinus Pressure
12 EFFERVESCENT TABLETS
NEW NIGHT DOSING DIRECTIONS
NIGHT
Aspirin (NSAID)/Pain Reliever-Fever Reducer
Dextromethorphan HBr/Cough Suppressant
Doxylamine Succinate/Antihistamine
Phenylephrine Bitartrate/Nasal Decongestant
- Nasal congestion
- Headache + Body Ache
- Cough
- Runny Nose
- Sore Throat
8 EFFERVESCENT TABLETS
Section 53413-1 (53413-1)
Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Section 55106-9 (55106-9)
Active ingredients (in each tablet) Purposes
Aspirin 325 mg (NSAID)*…….………………………..Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg……………………Cough suppressant
Phenylephrine bitartrate 7.8 mg.......……....…....…………..Nasal decongestant
*nonsteroidal anti-inflammatory drug
Section 60561-8 (60561-8)
Other information
- each tablet contains: potassium 78 mg; sodium 356 mg
- store at room temperature. Avoid excessive heat.
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Source: dailymed · Ingested: 2026-02-15T12:07:29.009281 · Updated: 2026-03-14T23:11:00.469021