Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night Effervescent Tablets UI 1614460 & 1614459

SPL UNCLASSIFIED SECTION

Drug Facts

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

OTC - ACTIVE INGREDIENT SECTION

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 & USAGE SECTION

Uses

temporarily relieves these symptoms due to a cold with cough: minor aches and painsheadachesinus congestion and pressurecoughsore throatnasal congestion
temporarily reduces fever

WARNINGS SECTION

Warnings

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.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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 diabetescough that occurs with excessive phlegm (mucus)difficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma, or emphysemaa sodium-restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

taking a prescription drug for goutdiabetesarthritis

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage.

OTC - STOP USE SECTION

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 faintvomit bloodhave bloody or black stoolshave 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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other information

each tablet contains: potassium 80 mg; sodium 356 mg
store at room temperature. Avoid excessive heat.

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Alka-Seltzer Plus® Cold PowerFast Fizz Night Effervescent Tablets

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet) Purposes

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

Chlorpheniramine maleate 2mg ……….……..…..………...…Antihistamine

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

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

*nonsteroidal anti-inflammatory drug

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

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:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

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.

hives
facial swelling ·
asthma (wheezing)
shock

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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 asthmadiabetesthyroid 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

taking a prescription drug for goutdiabetesarthritis
taking sedatives or tranquilizers

OTC - WHEN USING SECTION

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 SECTION

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 faintvomit bloodhave bloody or black stoolshave 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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other information

each tablet contains: potassium 80 mg; sodium 356 mg
store at room temperature. Avoid excessive heat.

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

Fri 9AM – 5PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

16 EFFERVESCENT TABLETS

NEW NIGHT DOSING DIRECTIONS

NIGHT

Aspirin (NSAID)/Pain Reliever-Fever Reducer

Chlorpheniramine maleate/Antihistamine

Dextromethorphan HBr/Cough Suppressant

Phenylephrine Bitartrate/Nasal Decongestant

8 EFFERVESCENT TABLETS

Nasal Decongestant
Headache + Body Ache
Cough
Sore Throat
Sinus Pressure