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 congestion · sinus temporarily reduces fever
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2025-12-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 01:20:03
Label at a glance#
ProductAlka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz
Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each tablet) Purposes
Acetaminophen 325 mg…………….………...Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg……………………..……..Antihistamine
Dextromethorphan hydrobromide 10 mg……………Cough suppressant
Phenylephrine hydrochloride 5 mg………………….Nasal decongestant
Uses
temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- cough
- sore throat
- runny nose
- sneezing
- nasal congestion · sinus
temporarily reduces fever
WARNINGS SECTION
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
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.
Do not use to sedate children.
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
OTC - WHEN USING SECTION
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
OTC - STOP USE SECTION
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
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.
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 10 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 356 mg
store at room temperature. Avoid excessive heat.
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose
OTC - QUESTIONS SECTION
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
MAXIMUM STRENGTH
Sinus
Congestion
& Pain
PowerFast Fizz™
Berry
New!
Actaminophen/Pain Reliever-Fever Reducer
Chlorpheniramine Maleate/Antihistamine
Dextromethorphan HBr/Cough Supressant
Phenylephrine Hydrochloride/Nasal Decongestant
- Sinus Congestion & Pressure
- Nasal Congestion
- Headache, Body Ache, Sore Throat
- Runny Nose, Sneezing
- Cough
24 EFFERVESCENT TABLETS
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2557336 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral Tablet | PSN | 6 |
| 2557336 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral Tablet | SCD | 6 |
| 2557336 | APAP 325 / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral Tablet | SY | 6 |
| 2557336 | APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral Tablet | SY | 6 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0016500598916 | GTIN-13: 0016500598916 EAN-13: 0016500598916 GTIN-12: 016500598916 UPC-A: 016500598916 GTIN storage (14 digits): 00016500598916 | ASP Sinus Congestion and Pain Berry PFF 24ct.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0055-01 | Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 6 | |
| 0280-0055-01 | Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 6 | |
| 0280-0055-02 | Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz | 12 in 1 CARTON | TABLET, EFFERVESCENT | 12 | 6 | |
| 0280-0055-02 | Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-0055-02 | EA - Each | 0280-0055 | 7ec5042c-4a74-46cc-8b8d-97df1dd75c39 | 1 | 2025-05-14 |
Products#
Every source-derived product name is available through these pages.
- Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz
- chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- CALCIUM SILICATE
- MANNITOL
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- MAGNESIUM STEARATE
- POTASSIUM BICARBONATE
- SODIUM BICARBONATE
- SUCRALOSE
- POVIDONE, UNSPECIFIED
- MALTODEXTRIN
- ACETAMINOPHEN
- ANHYDROUS CITRIC ACID
- DIMETHICONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-0055 | 0280-0055-01, 0280-0055-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | bd97e91f-1ae1-379c-e053-2995a90acfdd | 2025-12-04 | Warnings | 0280-0055-02 0280-0055-01 0280-0055 00280005501 00280005502 45261b62-142d-8c69-e063-6294a90a011f bd97e91f-1ae1-379c-e053-2995a90acfdd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.