Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz

Manufacturer
Select Corporation
Effective date
2022-05-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:34

Label at a glance#

ProductAlka Seltzer Plus Severe Cold and Flu PowerFast Fizz
Active ingredientAcetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Chlorpheniramine maleate
Label structure9 sections

Indications and 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

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purposes
Acetaminophen 250 mgPain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Dextromethorphan hydrobromide 10 mgCough suppressant
Phenylephrine hydrochloride 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • 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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

Do not use

OTC - DO NOT USE SECTION

  • 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 before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Blister Pack
PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Blister Pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Effervescent Oral TabletPSN2
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral TabletSCD2
1536477APAP 250 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine Hydrochloride 5 MG Effervescent Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-830-04Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT22
52904-830-04Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz1 in 1 BLISTER PACKTABLET, EFFERVESCENT12
52904-830-05Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 BLISTER PACKTABLET, EFFERVESCENT22
52904-830-05Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT22
52904-830-20Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT22
52904-830-20Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz20 in 1 CARTONTABLET, EFFERVESCENT202
52904-830-25Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT22
52904-830-25Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz25 in 1 CARTONTABLET, EFFERVESCENT252
52904-830-30Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz30 in 1 CARTONTABLET, EFFERVESCENT302
52904-830-30Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-830ALKA SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, EFFERVESCENT) TABLET, EFFERVESCENT [SELECT CORPORATION]2Legacy NDC, 10 package rows20220514_00c4b91d-2edf-4090-9de3-7eac35d7428c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52904-83052904-830-04, 52904-830-05, 52904-830-20, 52904-830-25, 52904-830-30
0280-0022

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
eda1d1c6-b5f4-4b40-89c5-ee0c44a78ee300c4b91d-2edf-4090-9de3-7eac35d7428c2022-05-12WarningsExact identifier
spl id: eda1d1c6-b5f4-4b40-89c5-ee0c44a78ee3
spl set id: 00c4b91d-2edf-4090-9de3-7eac35d7428c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.