Alka-Seltzer Plus Severe Cold & Cough PowerFast Fizz Effervescent Tablets

Manufacturer
Bayer Healthcare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:19:59

Label at a glance#

ProductAlka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Indications and uses

Uses temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold the intensity of coughing helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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 12 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet) Purposes

Dextromethorphan hydrobromide 10 mg………….…Cough suppressant

Guaifenesin 200 mg.......…………….….................................Expectorant

Uses

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a cold
  • the intensity of coughing
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS SECTION

Warnings

Do not use

● 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

● cough that occurs with excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ● a sodium-restricted diet

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

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

Directions

DOSAGE & ADMINISTRATION SECTION

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 12 tablets in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

OTHER SAFETY INFORMATION

Other information
● each tablet contains: potassium 80 mg; sodium 237 mg

● store at room temperature. Avoid excessive heat.

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavors, magnesium stearate, mannitol, potassium bicarbonate, sodium bicarbonate, sucralose

Questions or comments

OTC - QUESTIONS SECTION

Questions or comments? 1-800-986-0369 (Mon - Fri 9AM - 5PM EST)

Carton 24 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASP Cough and Chest Congestion Cool Blueberry Pomegranate 24ctASP Cough and Chest Congestion Cool Blueberry Pomegranate 24ctAlka Seltzer Plus Maximum Strength Cough & Chest Congestion

POWERFAST FIZZ™

Dextromethorphan HBr / Cough Suppressant

Guaifenesin/Expectorant

24 EFFERVESCENT TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2598125dextromethorphan hydrobromide 10 MG / guaiFENesin 200 MG Effervescent Oral TabletPSN12
2598125dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Effervescent Oral TabletSCD12

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130016500598923GTIN-13: 0016500598923
EAN-13: 0016500598923
GTIN-12: 016500598923
UPC-A: 016500598923
GTIN storage (14 digits): 00016500598923
ASP Cough and Chest Congestion Cool Blueberry Pomegranate PFF 24ct.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0089-01Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT212
0280-0089-01Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz20 in 1 CARTONTABLET, EFFERVESCENT2012
0280-0089-02Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT212
0280-0089-02Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz12 in 1 CARTONTABLET, EFFERVESCENT1212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-0089-02EA - Each0280-0089e5aed6e7-0cd2-423e-8688-d6fa00f0c2d612025-05-14

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-00890280-0089-01, 0280-0089-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast FizzDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINBayer Healthcare LLC.a32e2a5e-9aa0-4e7c-e053-2995a90a31902025-12-04WarningsExact identifier
ndc (package): 0280-0089-02
ndc (package): 0280-0089-01
ndc (product): 0280-0089
ndc11 (package): 00280008901
ndc11 (package): 00280008902
spl id: 4526573a-7900-980c-e063-6394a90a5fbd
spl set id: a32e2a5e-9aa0-4e7c-e053-2995a90a3190

Reported adverse events (FAERS/openFDA)#

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