Alka-seltzer Plus ®

Alka-seltzer Plus ®
SPL v4
SPL
SPL Set ID e7a27773-69d6-9e07-e053-2a95a90af8ea
Route
ORAL
Published
Effective Date 2022-05-17
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
Potassium Bicarbonate Povidone, Unspecified Sodium Bicarbonate Anhydrous Citric Acid Dimethicone Magnesium Stearate Maltodextrin Sucralose Calcium Silicate Fd&c Red No. 40 Fd&c Yellow No. 6 Mannitol

Identifiers & Packaging

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

Description

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

Purpose

Purposes Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant


Medication Information

Purpose

Purposes Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant

Description

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

Uses

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

Do not use to sedate children

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 53414-9

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

Purposes

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

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
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
Ask A Doctor

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
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.
Active Ingredients

Active ingredients (in each tablet)

Acetaminophen 250 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Pdp/package Basix

Alka-

Seltzer

Plus ®

CITRUS

FLAVOR

SEVERE Cold & Flu

POWERFAST FIZZ™

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

4

Effervescent Tablets

[TRAVEL

BASIX logo]

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.

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)

Pdp/package Lil Drug Store

Alka-

Seltzer

Plus ®

CITRUS

FLAVOR

SEVERE Cold & Flu

POWERFAST FIZZ™

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

4

Effervescent Tablets

[Lil' Drug Store logo]

Pdp/package Alka Selter Plus Cold & Flu, Cvp

Alka-

Seltzer

Plus ®

CITRUS

FLAVOR

SEVERE Cold & Flu

POWERFAST FIZZ™

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

4

Effervescent Tablets

[CVP HEALTH logo]

Alka Seltzer Plus Cold & Flu, 25ct Unit Dose Box

Alka-

Seltzer

PLUS ®

CITRUS

FLAVOR

SEVERE COLD & FLU

POWERFAST FIZZ™

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

2 EFFERVESCENT TABLETS PER POUCH

Alka Seltzer Plus Cold & Flu, 30ct Unit Dose Box

Alka-

Seltzer

PLUS ®

CITRUS

FLAVOR

SEVERE COLD & FLU

POWERFAST FIZZ™

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

2 EFFERVESCENT TABLETS PER POUCH


Structured Label Content

Uses

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)

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 53414-9 (53414-9)

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

Purposes

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

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
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
Ask A Doctor (Ask a doctor)

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
Allergy Alert (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)

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)

Other information

  • each tablet contains: potassium 80 mg; sodium 356 mg
  • store at room temperature. Avoid excessive heat.
Active Ingredients (Active ingredients)

Active ingredients (in each tablet)

Acetaminophen 250 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Pdp/package Basix (PDP/Package - BASIX)

Alka-

Seltzer

Plus ®

CITRUS

FLAVOR

SEVERE Cold & Flu

POWERFAST FIZZ™

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

4

Effervescent Tablets

[TRAVEL

BASIX logo]

Sore Throat Warning (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.

Inactive Ingredients (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?)

Questions or comments?

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

Pdp/package Lil Drug Store (PDP/Package - Lil Drug Store)

Alka-

Seltzer

Plus ®

CITRUS

FLAVOR

SEVERE Cold & Flu

POWERFAST FIZZ™

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

4

Effervescent Tablets

[Lil' Drug Store logo]

Pdp/package Alka Selter Plus Cold & Flu, Cvp (PDP/Package - Alka-Selter Plus Cold & Flu, CVP)

Alka-

Seltzer

Plus ®

CITRUS

FLAVOR

SEVERE Cold & Flu

POWERFAST FIZZ™

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

4

Effervescent Tablets

[CVP HEALTH logo]

Alka Seltzer Plus Cold & Flu, 25ct Unit Dose Box (Alka-Seltzer Plus Cold & Flu, 25ct Unit Dose Box)

Alka-

Seltzer

PLUS ®

CITRUS

FLAVOR

SEVERE COLD & FLU

POWERFAST FIZZ™

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

2 EFFERVESCENT TABLETS PER POUCH

Alka Seltzer Plus Cold & Flu, 30ct Unit Dose Box (Alka-Seltzer Plus Cold & Flu, 30ct Unit Dose Box)

Alka-

Seltzer

PLUS ®

CITRUS

FLAVOR

SEVERE COLD & FLU

POWERFAST FIZZ™

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

2 EFFERVESCENT TABLETS PER POUCH


Advanced Ingredient Data


Raw Label Data

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