Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2025-12-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:20:04
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets
OTC - ACTIVE INGREDIENT SECTION
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
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves these symptoms due to a cold with cough:
- minor aches and pains
- headache
- sinus congestion and pressure
- cough
- sore throat
- nasal congestion
- 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.
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 itsingredients
● 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 •thyroid •disease diabetes
- cough that occurs 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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for
- gout
- diabetes
- arthritis
OTC - WHEN USING SECTION
When using this product do not exceed recommended dosage.
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, 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 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 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.
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
- do not take more than the recommended dose
- do not take the Day and Night products at the same time; wait 4 hours after taking the last Night dose before taking the Day product
- adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
- children under 12 years: do not use
OTHER SAFETY INFORMATION
Other information
- each tablet contains: potassium 78 mg; sodium 356 mg
- store at room temperature. Avoid excessive heat.
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose
OTC - QUESTIONS SECTION
Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
SPL UNCLASSIFIED SECTION
Alka-Seltzer Plus® Cold PowerFast Fizz Night Effervescent Tablets
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each tablet) Purposes
Aspirin 325 mg (NSAID)*…….…………………..Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg……..…..……Cough suppressant
Doxylamine succinate 6.25 mg………………..…..………...…Antihistamine
Phenylephrine bitartrate 7.8 mg.......…………..…...….Nasal decongestant
*nonsteroidal anti-inflammatory drug
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- headache
- runny nose
- sinus congestion and pressure
- cough
- sneezing
- sore throat
- nasal congestion
- 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
- artake 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 that occurs 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
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
- 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 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 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.
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
- do not take more than the recommended dose
- do not take the Day and Night products at the same time; wait 4 hours after taking the last Day dose before taking the Night product
- adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
- children under 12 years: do not use
OTHER SAFETY INFORMATION
Other information
- each tablet contains: potassium 78 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
Alka-Seltzer Plus®
SEVERE COLD
DAY/CITRUS
NIGHT LEMON
POWERFAST FIZZ™
DAY NON-DROWSY
ASPIRIN (NSAID)/Pain Reliever - Fever Reducer
DEXTROMETHORPHAN HBr/Cough Suppressant
PHENYLEPHRINE BITARTRATE/Nasal Decongestant
- Nasal Decongestant
- Headache + Body Ache
- Cough
- Sore Throat
- Sinus Pressure
12 EFFERVESCENT TABLETS
NEW NIGHT DOSING DIRECTIONS
NIGHT
Aspirin (NSAID)/Pain Reliever-Fever Reducer
Dextromethorphan HBr/Cough Suppressant
Doxylamine Succinate/Antihistamine
Phenylephrine Bitartrate/Nasal Decongestant
- Nasal congestion
- Headache + Body Ache
- Cough
- Runny Nose
- Sore Throat
8 EFFERVESCENT TABLETS
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2565492 | {1 (aspirin 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 (aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) } Pack | GPCK | 5 |
| 2565492 | 1 daytime (aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 nighttime (aspirin 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) Pack | PSN | 5 |
| 2565491 | aspirin 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | 5 |
| 1536498 | aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | 5 |
| 2565491 | aspirin 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 5 |
| 1536498 | aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 5 |
| 2565492 | 1 daytime (aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 nighttime (aspirin 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) Pack | SY | 5 |
| 2565491 | ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 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 |
| DOXYLAMINE 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 | 0016500594604 | GTIN-13: 0016500594604 EAN-13: 0016500594604 GTIN-12: 016500594604 UPC-A: 016500594604 GTIN storage (14 digits): 00016500594604 | ASP COLD PF DAY NIGHT TAEF 20S (1).jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0069-01 | Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | 1 in 1 CARTON | KIT | 1 | 5 |
Products#
Every source-derived product name is available through these pages.
- Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night
- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate
- Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy
- asprin, dextromethorphan hydrobromide, phenylephrine bitartrate
- MANNITOL
- POTASSIUM BICARBONATE
- POVIDONE
- SODIUM BICARBONATE
- ASPIRIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE BITARTRATE
- PHENYLEPHRINE
- CALCIUM SILICATE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- SUCRALOSE
- ANHYDROUS CITRIC ACID
- DIMETHICONE
- Alka-Seltzer Plus Severe Cold Night PowerFast Fizz
- aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-0069 | 0280-0069-01 |
| 0280-0024 | |
| 0280-0068 |
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 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 |
| Alka-Seltzer Plus Severe Cold Night PowerFast Fizz | ASPIRIN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | c1fae6c7-bbac-1320-e053-2a95a90aac5a | 2026-01-08 | Warnings | 0280-0068 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | c2232241-6e57-1427-e053-2995a90a488a | 2025-12-04 | Warnings | 0280-0069-01 0280-0069 00280006901 45264ea9-aed7-8b75-e063-6394a90a74c1 c2232241-6e57-1427-e053-2995a90a488a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
