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FDA LABEL GENERIC: Aspirin MFR: Bayer HealthCare LLC.

1 Daytime (aspirin 325 Mg / Dextromethorphan Hbr 10 Mg / Phenylephrine Bitartrate 7.8 Mg Effervescent Oral Tablet) / 1 Nighttime (aspirin 325 Mg / Dextromethorphan Hbr 10 Mg / Doxylamine Succinate 6.25 Mg / Phenylephrine Bitartrate 7.8 Mg Effervescent Oral Tablet) Pack

Table of Contents

Drug Facts

Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets

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

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

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 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.

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

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

Other information

each tablet contains: potassium 78 mg; sodium 356 mg store at room temperature. Avoid excessive heat.

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

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

Alka-Seltzer Plus® Cold PowerFast Fizz Night Effervescent Tablets

Active ingredients (in each tablet) Purposes

Aspirin 325 mg (NSAID)*…….…………………..Pain reliever/fever reducer

Dextromethorphan hydrobromide 10 mg……..…..……Cough suppressant

Doxylamine succinate 6.25 mg………………..…..………...…Antihistamine

Phenylephrine bitartrate 7.8 mg.......…………..…...….Nasal decongestant

*nonsteroidal anti-inflammatory drug

INDICATIONS AND USAGE

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 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 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.

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

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 Day dose before taking the Night 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

Other information

each tablet contains: potassium 78 mg; sodium 356 mg store at room temperature. Avoid excessive heat.

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Questions or comments? 1-800-986-0369 (Mon-

Fri 9AM – 5PM EST)

ASK A DOCTOR

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