Indications and uses
temporarily relieves these symptoms due to a cold: minor aches and pains headache runny nose nasal congestion sneezing sore throat sinus congestion and pressure temporarily reduces fever
Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2025-12-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 01:20:03
Label at a glance#
ProductAlka-Seltzer Plus Cold Sparkling Original PowerFast Fizz
Active ingredientASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE
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
Aspirin 325 mg (NSAID)*…..………….……..Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg.……………..…...…….....Antihistamine
Phenylephrine bitartrate 7.8 mg …........…………...Nasal decongestant
*nonsteroidal anti-inflammatory drug
Uses
temporarily relieves these symptoms due to a cold:
- minor aches and pains
- headache
- runny nose
- nasal congestion
- sneezing
- sore throat
- sinus congestion and pressure
temporarily reduces fever
WARNINGS SECTION
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
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
● hives
● facial swelling
● asthma (wheezing)
● shock
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
Do not use to sedate children.
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 - STOP USE SECTION
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- gout
- diabetes
- arthritis
taking sedatives or tranquilizers
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.
DOSAGE & ADMINISTRATION SECTION
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
Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, 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
Severe Cold
Sparkling Original
POWERFAST FIZZ™
NEW LESS RESIDUE
ASPIRIN (NSAID)/Pain Reliever-Fever Reducer
Chlorpheniramine 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 | 7 |
| 1536840 | aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 7 |
| 1536840 | ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 7 |
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 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0016500598886 | GTIN-13: 0016500598886 EAN-13: 0016500598886 GTIN-12: 016500598886 UPC-A: 016500598886 GTIN storage (14 digits): 00016500598886 | ASP Severe Cold Sparkling Original PFF 24CT.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0060-01 | Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 7 | |
| 0280-0060-01 | Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 7 | |
| 0280-0060-02 | Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | 18 in 1 CARTON | TABLET, EFFERVESCENT | 18 | 7 | |
| 0280-0060-02 | Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 7 | |
| 0280-0060-03 | Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | 2 in 1 CARTON | TABLET, EFFERVESCENT | 2 | 7 | |
| 0280-0060-03 | Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 7 | |
| 0280-0060-04 | Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 7 | |
| 0280-0060-04 | Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | 12 in 1 CARTON | TABLET, EFFERVESCENT | 12 | 7 | |
| 0280-0060-05 | Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 7 | |
| 0280-0060-06 | Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | 24 in 1 CARTON | TABLET, EFFERVESCENT | 24 | 7 | |
| 0280-0060-06 | Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 7 |
Products#
Every source-derived product name is available through these pages.
- Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz
- aspirin, chlorpheniramine maleate, phenylephrine bitartrate
- DIMETHICONE
- POTASSIUM BICARBONATE
- SUCRALOSE
- ASPIRIN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- PHENYLEPHRINE BITARTRATE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- CALCIUM SILICATE
- MANNITOL
- SODIUM BICARBONATE
- POVIDONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-0060 | 0280-0060-01, 0280-0060-02, 0280-0060-03, 0280-0060-04, 0280-0060-05, 0280-0060-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIMETHICONE | 92RU3N3Y1O | IACT |
| POTASSIUM BICARBONATE | HM5Z15LEBN | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| PHENYLEPHRINE BITARTRATE | 27O3Q5ML57 | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| CALCIUM SILICATE | S4255P4G5M | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| POVIDONE | FZ989GH94E | 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 Cold Sparkling Original PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | bd49121c-7cba-c51f-e053-2995a90a921e | 2025-12-04 | Warnings | 0280-0060-02 0280-0060-01 0280-0060-03 0280-0060-04 0280-0060-05 0280-0060-06 0280-0060 00280006001 00280006003 00280006004 00280006006 00280006005 00280006002 45262c76-563e-6aee-e063-6394a90af808 bd49121c-7cba-c51f-e053-2995a90a921e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.