Alka-seltzer Plus Severe Cold & Flu Effervescent Tablets

Alka-seltzer Plus Severe Cold & Flu Effervescent Tablets
SPL v3
SPL
SPL Set ID 531a86b3-2915-6d55-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2018-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (250 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Fd&c Red No. 40 Magnesium Stearate Maltodextrin Mannitol Saccharin Sodium Sodium Bicarbonate

Identifiers & Packaging

Pill Appearance
Imprint: ASP;FLU Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-07-03

Description

Active ingredients (in each tablet) Acetaminophen 250 mg Chlorpheniramine maleate 2 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg


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

Dosage and Administration

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

Description

Active ingredients (in each tablet) Acetaminophen 250 mg Chlorpheniramine maleate 2 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg

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 acesulfame potassium, anhydrous citric acid, aspartame, FD&C red #40, flavors, magnesium stearate, maltodextrin, mannitol, saccharin sodium, sodium bicarbonate

Section 51945-4

Alka-Seltzer

PLUS®

SEVERE

Cold

& Flu

CITRUS

Acetaminophen / Pain Reliever-Fever Reducer

Chlorpheniramine Maleate / Antihistamine

Dextromethorphan HBr / Cough Suppressant

Phenylephrine Hydrochloride / Nasal Decongestant

  • Fever & Body Ache
  • Cough
  • Nasal Congestion
  • Runny Nose
  • Sore Throat

20 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.

Section 55105-1

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Section 55106-9

Active ingredients (in each tablet)

Acetaminophen 250 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Section 60561-8

Other information

● each tablet contains: sodium 416 mg

● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet

● store at room temperature. Avoid excessive heat.


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

Dosage and Administration (34068-7)

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

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 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 acesulfame potassium, anhydrous citric acid, aspartame, FD&C red #40, flavors, magnesium stearate, maltodextrin, mannitol, saccharin sodium, sodium bicarbonate

Section 51945-4 (51945-4)

Alka-Seltzer

PLUS®

SEVERE

Cold

& Flu

CITRUS

Acetaminophen / Pain Reliever-Fever Reducer

Chlorpheniramine Maleate / Antihistamine

Dextromethorphan HBr / Cough Suppressant

Phenylephrine Hydrochloride / Nasal Decongestant

  • Fever & Body Ache
  • Cough
  • Nasal Congestion
  • Runny Nose
  • Sore Throat

20 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.

Section 55105-1 (55105-1)

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Acetaminophen 250 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Section 60561-8 (60561-8)

Other information

● each tablet contains: sodium 416 mg

● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet

● store at room temperature. Avoid excessive heat.


Advanced Ingredient Data


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