Alka-seltzer Plus ®

Alka-seltzer Plus ®
SPL v4
SPL
SPL Set ID d786ae07-ce57-44c7-9ba5-f4c87df115de
Route
ORAL
Published
Effective Date 2023-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: ASP;FLU Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-16

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves these symptoms due to a cold or flu:
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

Section 50570-1

Do not use to sedate children.

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 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.

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 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
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.

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.
Inactive Ingredients

anhydrous citric acid, calcium silicate, dimethicone, FDC red #40, FDC yellow #6, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povioone, sodium bicarbonate, sucralose.

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 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
Principal Display Panel 60 Tablet Carton

Alka-

Seltzer

PLUS ®


Acetaminophen / Pain reliever/fever reducer

Chlorpheniramine maleate / Antihistamine

Dextromethorphan hydrobromide / Cough suppressant

Phenylephrine hydrochloride / Nasal decongestant

COLD

FORMULA

SPARKLING

ORIGINAL

Nasal Congestion • Runny Nose

Headache & Body Ache

Sore Throat • Sinus Pressure

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves these symptoms due to a cold or flu:
  • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Section 50570-1 (50570-1)

Do not use to sedate children.

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 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.

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 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
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.

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.

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.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, calcium silicate, dimethicone, FDC red #40, FDC yellow #6, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povioone, sodium bicarbonate, sucralose.

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 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
Principal Display Panel 60 Tablet Carton (PRINCIPAL DISPLAY PANEL - 60 Tablet Carton)

Alka-

Seltzer

PLUS ®


Acetaminophen / Pain reliever/fever reducer

Chlorpheniramine maleate / Antihistamine

Dextromethorphan hydrobromide / Cough suppressant

Phenylephrine hydrochloride / Nasal decongestant

COLD

FORMULA

SPARKLING

ORIGINAL

Nasal Congestion • Runny Nose

Headache & Body Ache

Sore Throat • Sinus Pressure

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)