Alka-seltzer Plus Severe Cold & Flu Effervescent Tablets
531a86b3-2915-6d55-e054-00144ff88e88
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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.
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:56:56.470744 · Updated: 2026-03-14T22:55:45.140912