Indications and uses
Uses · temporarily relieves these symptoms due to a cold with cough: · minor aches and pains · headache · cough · nasal and sinus congestion · sore throat · temporarily reduces fever
Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2026-01-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:52:27
Label at a glance#
ProductAlka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy
Active ingredientASPIRIN, PHENYLEPHRINE BITARTRATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections
Dosage and administration
Directions ● 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
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients
Active ingredients (in each tablet) Purposes
Aspirin 325 mg (NSAID)*…….……………….Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg……………Cough suppressant
Phenylephrine bitartrate 7.8 mg.......……....…...…..Nasal decongestant
*nonsteroidal anti-inflammatory drug
Uses
Uses
· temporarily relieves these symptoms due to a cold with cough:
· minor aches and pains · headache · cough
· nasal and sinus congestion · sore throat
· temporarily reduces fever
Warnings
Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
· hives · facial swelling · asthma (wheezing) · shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
● are age 60 or older
● have had stomach ulcers or bleeding problems
● take a blood thinning (anticoagulant) or steroid drug
● take other drugs containing prescription or nonprescription NSAIDs
(aspirin, ibuprofen, naproxen, or others)
● have 3 or more alcoholic drinks every day while using this product
● take more or for a longer time than directed
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
Do not use
● if you are allergic to aspirin or any other pain reliever/fever reducer
● 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
● stomach bleeding warning applies to you
● you have a history of stomach problems, such as heartburn
● you have high blood pressure, heart disease, liver cirrhosis,
or kidney disease
● you are taking a diuretic
● you have
● asthma ● thyroid disease ● diabetes
● cough with excessive phlegm (mucus)
● 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
Ask a doctor or pharmacist before use if you are
· taking a prescription drug for
· gout · diabetes · arthritis
When using this product
When using this product do not exceed recommended dosage
Stop use
Stop use and ask a doctor if
· an allergic reaction occurs. Seek medical help right away.
● you experience any of the following signs of stomach bleeding
● feel faint ● vomit blood ● have bloody or black stools
● have stomach pain that does not get better
· 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
· ringing in the ears or a loss of hearing occurs
· cough comes back or occurs with rash or headache that lasts. These
could be signs of a serious condition.
· nervousness, dizziness, or sleeplessness occurs
Pregnant or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Directions
● 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
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, FD&C red #40, FD&C yellow #6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose
Questions
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM – 5PM EST)
Carton 20 count
Alka-Seltzer Plus®
SEVERE
Cold
CITRUS
POWERFAST™ FIZZ
NEW IMPROVED FLAVOR
NON-DROWSY
ASPIRIN (NSAID) / Pain Reliever-Fever Reducer
Dextromehorphan HBr / Cough Suppressant
Phenylephrine Bitartrate / Nasal Decongestant
- Fever + Body Ache
- Nasal Congestion
- Sinus Pressure
- Sore Throat
- Cough
20 EFFERVESCENT TABLETS
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1536498 | aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | 5 |
| 1536498 | aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 5 |
| 1536498 | ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 5 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| 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 | 0016500590965 | GTIN-13: 0016500590965 EAN-13: 0016500590965 GTIN-12: 016500590965 UPC-A: 016500590965 GTIN storage (14 digits): 00016500590965 | ASP PFF Cold_20ct_Ctn2.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0024-01 | Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 5 | |
| 0280-0024-01 | Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 5 | |
| 0280-0024-02 | Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 5 | |
| 0280-0024-02 | Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy | 24 in 1 CARTON | TABLET, EFFERVESCENT | 24 | 5 |
Products#
Every source-derived product name is available through these pages.
- Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy
- asprin, dextromethorphan hydrobromide, phenylephrine bitartrate
- MANNITOL
- SODIUM BICARBONATE
- ASPIRIN
- PHENYLEPHRINE BITARTRATE
- PHENYLEPHRINE
- CALCIUM SILICATE
- DIMETHICONE
- FD&C RED NO. 40
- ANHYDROUS CITRIC ACID
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- FD&C YELLOW NO. 6
- POVIDONE, UNSPECIFIED
- SUCRALOSE
- POTASSIUM BICARBONATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-0024 | 0280-0024-01, 0280-0024-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MANNITOL | 3OWL53L36A | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| PHENYLEPHRINE BITARTRATE | 27O3Q5ML57 | ACTIB |
| CALCIUM SILICATE | S4255P4G5M | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| POTASSIUM BICARBONATE | HM5Z15LEBN | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2023-12-11 | full-release | 2026-06-01 00:03:54 |
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 Severe Cold PowerFast Fizz Non Drowsy | ASPRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a355d987-77ce-9e32-e053-2995a90a6431 | 2026-01-08 | Warnings | 0280-0024-01 0280-0024-02 0280-0024 00280002402 00280002401 47e317c2-ea4e-8cce-e063-6394a90a9182 a355d987-77ce-9e32-e053-2995a90a6431 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.