Indications and uses
Uses · temporarily relieves these symptoms due to a cold with cough: · minor aches and pains · headache · cough · runny nose · nasal and sinus congestion · sneezing · sore throat · temporarily reduces fever
Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz
- Manufacturer
- Bayer Healthcare LLC.
- Effective date
- 2025-12-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 13
- Source
- full-release
- Hydrated at
- 2026-06-01 01:20:07
Label at a glance#
ProductAlka-Seltzer Plus Severe Cold and Cough PowerFast Fizz
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each tablet) Purposes
Aspirin 325 mg (NSAID)*….……..…………...Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg……………..…………...…Antihistamine
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
· runny nose · nasal and sinus congestion
· sneezing · sore throat
· temporarily reduces fever
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
● 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
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
When using
When using this product
● do not exceed recommended dosage
· may cause marked drowsiness
● avoid alcoholic drinks
● excitability may occur, especially in children
● alcohol, sedatives, and tranquilizers may increase drowsiness
● be careful when driving a motor vehicle or operating machinery
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
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.
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 SAFETY INFORMATION
Other information
● each tablet contains: potassium 80 mg; sodium 356 mg
● store at room temperature. Avoid excessive heat.
INACTIVE INGREDIENT SECTION
anhydrous citric acid, calcium silicate, dimethicone,
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
Alka-Seltzer®
PLUS
SEVERE
Cold &
Cough
Citrus
POWERFAST FIZZ™
NEW IMPROVED FLAVOR
ASPIRIN (NSAID) / Pain Reliever Reducer
Chlorpheniramine Maleate / Antihistamine
Dextromethorphan HBr / Cough Suppressant
Phenyleprine Bitartrate / Nasal Decongestant
24 EFFERVESCENT TABLETS
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1537029 | aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | 13 |
| 1537029 | aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 13 |
| 1537029 | ASA 325 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 13 |
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 |
| 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 | 0016500598909 | GTIN-13: 0016500598909 EAN-13: 0016500598909 GTIN-12: 016500598909 UPC-A: 016500598909 GTIN storage (14 digits): 00016500598909 | ASP Severe Cold and Cough Citrus PFF 24ct.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7724692-1155-4cc8-a415-22f5fc4aec35 | Product name | 6 | 20220216 |
| bde672ba-4805-28d0-1986-73543d41b412 | Product name | 2 | 20210201 |
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 9425d234-4ae1-4b53-adc6-8cc7af6dd657 | Product name | 1 | 20150929 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0023-01 | Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 13 | |
| 0280-0023-01 | Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 13 | |
| 0280-0023-02 | Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 13 | |
| 0280-0023-02 | Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | 24 in 1 CARTON | TABLET, EFFERVESCENT | 24 | 13 | |
| 0280-0023-03 | Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | 12 in 1 CARTON | TABLET, EFFERVESCENT | 12 | 13 | |
| 0280-0023-03 | Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 13 |
Products#
Every source-derived product name is available through these pages.
- Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz
- aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate
- CALCIUM SILICATE
- DIMETHICONE
- ANHYDROUS CITRIC ACID
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ASPIRIN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- POVIDONE
- POTASSIUM BICARBONATE
- SUCRALOSE
- SODIUM BICARBONATE
- MANNITOL
- PHENYLEPHRINE BITARTRATE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-0023 | 0280-0023-01, 0280-0023-02, 0280-0023-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CALCIUM SILICATE | S4255P4G5M | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| POVIDONE | FZ989GH94E | IACT |
| POTASSIUM BICARBONATE | HM5Z15LEBN | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| PHENYLEPHRINE BITARTRATE | 27O3Q5ML57 | ACTIB |
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 and Cough PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer Healthcare LLC. | dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a | 2025-12-04 | Warnings | 0280-0023-02 0280-0023-03 0280-0023-01 0280-0023 00280002301 00280002303 00280002302 4523854a-cb4c-04b8-e063-6294a90a5c88 dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.