ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve Tablets UI 1614460 & 1614459
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2026-04-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-06-03 18:04:05
Label at a glance#
ProductALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve
Active ingredientASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, CHLORPHENIRAMINE MALEATE
Label structure18 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Alka-Seltzer Cold Cold + Congestion Severe 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:
- 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 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 •thyroid disease • diabetes
- cough that is accompanied by excessive phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- difficulty in urination due to enlargement of the prostate gland
- a sodium-restricted diet
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or 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
- cough comes back or occurs with rash or headache that lasts. These
- could be signs of a serious condition.
- ringing in the ears or loss of hearing occurs
- 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.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than the recommended dose
- 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 between 20 oC to 25 oC (68 oF to 77 oF). Avoid excessive heat above 40 oC (104 oF).
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 8AM – 8PM EST)
SPL UNCLASSIFIED SECTION
Alka-Seltzer Cold Cold + Congestion Severe Night Fast Dissolve Effervescent Tablets
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each tablet) Purposes
Aspirin 325 mg (NSAID)*…….…………………..Pain reliever/fever reducer
Chlorpheniramine maleate 2mg ……….……..…..………...…Antihistamine
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:
- 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
- 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 that is accompanied by excessive phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma,or emphysema
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- a sodium-restricted diet
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
- taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- do not exceed recommended dosage
- may cause marked drowsiness
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- avoid alcoholic drinks
- 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
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- ringing in the ears or loss of hearing occurs
- 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.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than the recommended dose
- 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 between 20 oC to 25 oC (68 oF to 77 oF). Avoid excessive heat above 40 oC (104 oF).
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 8AM – 8PM EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
.
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 | 1 |
| 1536498 | aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 1 |
| 1536498 | ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 1 |
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 | 0016500600688 | GTIN-13: 0016500600688 EAN-13: 0016500600688 GTIN-12: 016500600688 UPC-A: 016500600688 GTIN storage (14 digits): 00016500600688 | Final Artwork ASC Cold Cong Severe DN 48ct Eff.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve
- aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate
- Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy
- asprin, dextromethorphan hydrobromide, phenylephrine bitartrate
- ASPIRIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE BITARTRATE
- PHENYLEPHRINE
- CALCIUM SILICATE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- SUCRALOSE
- DIMETHICONE
- ANHYDROUS CITRIC ACID
- MANNITOL
- POTASSIUM BICARBONATE
- POVIDONE
- SODIUM BICARBONATE
- Alka-Seltzer Plus Severe Cold Night PowerFast Fizz
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-8285 | 0280-8285-24, 0280-8285-48 |
| 0280-0024 | |
| 0280-0121 |
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 COLD Cold Congestion Severe Day Night Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50738a43-7299-270c-e063-6294a90af2cc | 2026-04-27 | Warnings | 0280-8285-24 0280-8285-48 0280-8285 00280828548 00280828524 50738a43-7298-270c-e063-6294a90af2cc 50738a43-7299-270c-e063-6294a90af2cc |
| 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, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | fc754dff-cecd-fc6b-e053-6394a90ab371 | 2025-01-17 | Warnings | 0280-0121 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.