Alka-seltzer Plus Severe Cold & Cough Powerfast Fizz Effervescent Tablets Ui 1614459

Alka-seltzer Plus Severe Cold & Cough Powerfast Fizz Effervescent Tablets Ui 1614459
SPL v13
SPL
SPL Set ID dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a
Route
ORAL
Published
Effective Date 2020-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Aspirin (325 mg) Chlorpheniramine (2 mg) Phenylephrine (7.8 mg)
Inactive Ingredients
Calcium Silicate Dimethicone Anhydrous Citric Acid Povidone Potassium Bicarbonate Sucralose Sodium Bicarbonate Mannitol

Identifiers & Packaging

Pill Appearance
Imprint: ASP;CandC Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-01

Description

Drug Facts


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.

Do not use to sedate children.

Description

Drug Facts

Uses

Uses

· temporarily relieves these symptoms due to a cold with cough:

· minor aches and pains · headache · cough

· runny nose · nasal and sinus congestion

· sneezing · sore throat

· temporarily reduces fever

Section 42229-5

Drug Facts

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 50568-5

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

· gout · diabetes · arthritis

● taking sedatives or tranquilizers

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 ● 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

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 its

ingredients

● in children under 12 years of age

Section 51727-6



anhydrous citric acid, calcium silicate, dimethicone,

flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Section 53414-9

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.

Section 55106-9

Active ingredients (in each tablet) Purposes

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

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

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 80 mg; sodium 356 mg

● store at room temperature. Avoid excessive heat.

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 a 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

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

When Using

When using this product

● do not exceed recommended dosage

· may cause marked drowsiness

● avoid alcoholic drinks

● excitability may occur, especially in children

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

Carton 24 Count

Alka-Seltzer®

PLUS

SEVERE

Cold &

Cough

Citrus

POWERFAST FIZZ™

NEW IMPROVED FLAVOR

ASPIRIN (NSAID) / Pain Reliever Reducer

Chlorpheniramine Maleate / Antihistamine

Dextromethorphan HBr / Cough Suppressant

Phenyleprine Bitartrate / Nasal Decongestant

24 EFFERVESCENT TABLETS

Questions Or Comments

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


Structured Label Content

Uses

Uses

· temporarily relieves these symptoms due to a cold with cough:

· minor aches and pains · headache · cough

· runny nose · nasal and sinus congestion

· sneezing · sore throat

· temporarily reduces fever

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.

Do not use to sedate children.

Section 42229-5 (42229-5)

Drug Facts

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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

· gout · diabetes · arthritis

● taking sedatives or tranquilizers

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 ● 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

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 its

ingredients

● in children under 12 years of age

Section 51727-6 (51727-6)



anhydrous citric acid, calcium silicate, dimethicone,

flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Section 53414-9 (53414-9)

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.

Section 55106-9 (55106-9)

Active ingredients (in each tablet) Purposes

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

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

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 80 mg; sodium 356 mg

● store at room temperature. Avoid excessive heat.

Stop Use (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 a 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

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

When Using (When using)

When using this product

● do not exceed recommended dosage

· may cause marked drowsiness

● avoid alcoholic drinks

● excitability may occur, especially in children

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

Carton 24 Count (Carton 24 count)

Alka-Seltzer®

PLUS

SEVERE

Cold &

Cough

Citrus

POWERFAST FIZZ™

NEW IMPROVED FLAVOR

ASPIRIN (NSAID) / Pain Reliever Reducer

Chlorpheniramine Maleate / Antihistamine

Dextromethorphan HBr / Cough Suppressant

Phenyleprine Bitartrate / Nasal Decongestant

24 EFFERVESCENT TABLETS

Questions Or Comments (Questions or comments)

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


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