Alka-seltzer Plus Severe Cold & Flu Powerfast Fizz Ui1615106

Alka-seltzer Plus Severe Cold & Flu Powerfast Fizz Ui1615106
SPL v13
SPL
SPL Set ID a2f0285b-8550-fd26-e053-2995a90ab615
Route
ORAL
Published
Effective Date 2022-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Dextromethorphan (10 mg) Chlorpheniramine (2 mg) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Red No. 40 Anhydrous Citric Acid Sucralose Potassium Bicarbonate Sodium Bicarbonate Fd&c Yellow No. 6 Dimethicone Calcium Silicate Magnesium Stearate Maltodextrin Mannitol Povidone

Identifiers & Packaging

Pill Appearance
Imprint: ASP;CFSH Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-05

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

· more than 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

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

Indications and Usage

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · runny nose · sneezing

· nasal and sinus congestion

· temporarily reduces fever

Description

Drug Facts

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Section 50566-9



Stop use and ask a doctor if

· 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

· 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

● 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

Section 50568-5

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

● liver disease ● heart disease ● high blood pressure ● thyroid disease ● diabetes ● 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

● with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains

acetaminophen, ask a doctor or pharmacist.

● 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

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

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55106-9

Active ingredients (in each tablet) Purposes

Acetaminophen 250 mg…………….………...Pain reliever/fever reducer

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

Dextromethorphan hydrobromide 10 mg……………Cough suppressant

Phenylephrine hydrochloride 5 mg………………….Nasal decongestant

Section 60561-8

Other information

each tablet contains: potassium 80 mg; sodium 355 mg

● store at room temperature. Avoid excessive heat.

Directions

Directions

· do not take more than the recommended dose

· 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

Questions Or Comments

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


Structured Label Content

Indications and Usage (34067-9)

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · runny nose · sneezing

· nasal and sinus congestion

· temporarily reduces fever

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

· more than 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Section 50566-9 (50566-9)



Stop use and ask a doctor if

· 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

· 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

● 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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

● liver disease ● heart disease ● high blood pressure ● thyroid disease ● diabetes ● 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

● with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains

acetaminophen, ask a doctor or pharmacist.

● 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)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55106-9 (55106-9)

Active ingredients (in each tablet) Purposes

Acetaminophen 250 mg…………….………...Pain reliever/fever reducer

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

Dextromethorphan hydrobromide 10 mg……………Cough suppressant

Phenylephrine hydrochloride 5 mg………………….Nasal decongestant

Section 60561-8 (60561-8)

Other information

each tablet contains: potassium 80 mg; sodium 355 mg

● store at room temperature. Avoid excessive heat.

Directions

Directions

· do not take more than the recommended dose

· 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

Questions Or Comments (Questions or comments)

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


Advanced Ingredient Data


Raw Label Data

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