Alka Seltzer Plus®

SPL v2

SPL

SPL Set ID 00c4b91d-2edf-4090-9de3-7eac35d7428c

Route

ORAL

Published

Effective Date 2022-05-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (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

Drug Facts

Medication Information

Description

Drug Facts

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

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 53414-9

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

Section 55105-1

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

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

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

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.

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

Other Information

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

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.

Inactive Ingredients

anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Questions Or Comments?

1-800-986-0369 (Mon-Fri 9AM – 5PM EST)

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

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 a rash or headache that lasts. These could be signs of a serious condition.
nervousness, dizziness, or sleeplessness occurs

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Principal Display Panel 2 Tablet Pouch Blister Pack

Alka-

Seltzer

PLUS^®

ACETAMINOPHEN / Pain Reliever-Fever Reducer

Chlorpheniramine Maleate / Antihistamine

Dextromethorphan HBr / Cough Suppressant

Phenylephrine Hydrochloride / Nasal Decongestant

SEVERE

Cold

& Flu

CITRUS

• Fever & Body Ache • Cough • Nasal Congestion

• Runny Nose • Sore Throat

BAYER

POWER FAST FiZZ™

2

EFFERVESCENT

Tablets

Single-Pack

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

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

Do Not Use (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

Allergy Alert (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.

Liver Warning (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

Other Information (Other information)

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

Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Questions Or Comments? (Questions or comments?)

1-800-986-0369 (Mon-Fri 9AM – 5PM EST)

When Using This Product (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

Stop Use and Ask A Doctor If (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 a rash or headache that lasts. These could be signs of a serious condition.
nervousness, dizziness, or sleeplessness occurs

Ask A Doctor Before Use If You Have (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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Principal Display Panel 2 Tablet Pouch Blister Pack (PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Blister Pack)

Alka-

Seltzer

PLUS^®

ACETAMINOPHEN / Pain Reliever-Fever Reducer

Chlorpheniramine Maleate / Antihistamine

Dextromethorphan HBr / Cough Suppressant

Phenylephrine Hydrochloride / Nasal Decongestant

SEVERE

Cold

& Flu

CITRUS

• Fever & Body Ache • Cough • Nasal Congestion

• Runny Nose • Sore Throat

BAYER

POWER FAST FiZZ™

2

EFFERVESCENT

Tablets

Single-Pack

Advanced Ingredient Data

[{"name": "Acetaminophen", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "Dextromethorphan", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "Phenylephrine", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "Chlorpheniramine", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "acesulfame potassium", "unii": "23OV73Q5G9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "anhydrous citric acid", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C red no. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "magnesium stearate", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "maltodextrin", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "mannitol", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "saccharin sodium", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium bicarbonate", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "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", "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", "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", "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.", "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", "Other information": "each tablet contains: potassium 80 mg; sodium 356 mg store at room temperature. Avoid excessive heat.", "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.", "Inactive ingredients": "anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose", "Questions or comments?": "1-800-986-0369 (Mon-Fri 9AM – 5PM EST)", "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", "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 a rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs", "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", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin taking sedatives or tranquilizers", "PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Blister Pack": "Alka- Seltzer PLUS ® ACETAMINOPHEN / Pain Reliever-Fever Reducer Chlorpheniramine Maleate / Antihistamine Dextromethorphan HBr / Cough Suppressant Phenylephrine Hydrochloride / Nasal Decongestant SEVERE Cold & Flu CITRUS • Fever & Body Ache • Cough • Nasal Congestion • Runny Nose • Sore Throat BAYER POWER FAST FiZZ™ 2 EFFERVESCENT Tablets Single-Pack"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:13.691301 · Updated: 2026-03-14T23:00:34.965652