Indications and uses
Uses · temporarily relieves these symptoms due to a cold: · minor aches and pains · headache · runny nose · nasal and sinus congestion · sneezing · sore throat · temporarily reduces fever
Alka-Seltzer Plus Severe Cold PowerFast Fizz
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2025-01-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- full-release
- Hydrated at
- 2026-06-01 00:53:06
Label at a glance#
ProductAlka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest
Active ingredientPHENYLEPHRINE BITARTRATE, CHLORPHENIRAMINE MALEATE, ASPIRIN
Label structure10 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
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each tablet)
Aspirin 325 mg (NSAID)*
Chlorpheniramine maleate 2 mg
Phenylephrine bitartrate 7.8 mg
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
Uses
Uses
· temporarily relieves these symptoms due to a cold:
· minor aches and pains · headache · runny nose
· nasal and sinus congestion · sneezing · sore throat
· temporarily reduces fever
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
WARNINGS SECTION
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 to sedate children.
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
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 ● diabetes
● thyroid disease ● glaucoma
● difficulty in urination due to enlargement of the prostate gland
● a breathing problem such as emphysema or chronic bronchitis
● a sodium-restricted diet
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
· taking a prescription drug for
· gout · diabetes · arthritis
· taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
● do not exceed recommended dosage
● excitability may occur, especially in children
● you may get drowsy
● avoid alcoholic drinks
● alcohol, sedatives, and tranquilizers may increase drowsiness
● be careful when driving a motor vehicle or operating machinery
OTC - STOP USE SECTION
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 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
● nervousness, dizziness, or sleeplessness occur
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
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.
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 or Comments
Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
Carton 24 count
PowerFast Fizz™
NEW Improved Flavor
ASPIRIN (NSAID) / Pain Reliever-Fever Reducer
Chlorheniramine Maleate / Antihistamine
Phenylephrine Bitartrate / Nasal Decongestant
- Nasal Congestion
- Runny Nose
- Sore Throat
- Headache + Body Ache
- Sinus Pressure
24 EFFERVESCENT TABLETS
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1536840 | aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | 10 |
| 1536840 | aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 10 |
| 1536840 | ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 10 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0020-01 | Alka-Seltzer Plus Severe Cold PowerFast FizzOrange Zest | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 10 | |
| 0280-0020-01 | Alka-Seltzer Plus Severe Cold PowerFast FizzOrange Zest | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 10 | |
| 0280-0020-02 | Alka-Seltzer Plus Severe Cold PowerFast FizzOrange Zest | 12 in 1 CARTON | TABLET, EFFERVESCENT | 12 | 10 | |
| 0280-0020-02 | Alka-Seltzer Plus Severe Cold PowerFast FizzOrange Zest | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-0020 | ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ ORANGE ZEST (ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.] | 10 | Current NDC, Legacy NDC, 4 package rows | 20250119_a23a6db6-4585-2882-e053-2a95a90ab01a.zip |
Products#
Every source-derived product name is available through these pages.
- Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest
- aspirin, chlorpheniramine maleate, phenylephrine bitartrate
- PHENYLEPHRINE BITARTRATE
- PHENYLEPHRINE
- FD&C YELLOW NO. 6
- SUCRALOSE
- MANNITOL
- POTASSIUM BICARBONATE
- SODIUM BICARBONATE
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- POVIDONE
- ANHYDROUS CITRIC ACID
- ASPIRIN
- FD&C RED NO. 40
- CALCIUM SILICATE
- DIMETHICONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-0020 | 0280-0020-01, 0280-0020-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENYLEPHRINE BITARTRATE | 27O3Q5ML57 | ACTIB |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POTASSIUM BICARBONATE | HM5Z15LEBN | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| POVIDONE | FZ989GH94E | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| CALCIUM SILICATE | S4255P4G5M | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
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 Severe Cold PowerFast Fizz Orange Zest | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a23a6db6-4585-2882-e053-2a95a90ab01a | 2025-01-17 | Warnings | 0280-0020-01 0280-0020-02 0280-0020 00280002002 00280002001 2be96d7c-dcfc-3eaf-e063-6394a90a5220 a23a6db6-4585-2882-e053-2a95a90ab01a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.