Quick answers
- What is Aspirin, dextromethorphan, doxylamine and phenylephrine used for?
- The Drug Facts label of Alka-Seltzer Plus Cold Night (Bayer HealthCare LLC.) lists these uses: 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.
- Do I need a prescription for Aspirin, dextromethorphan, doxylamine and phenylephrine?
- No. The products on this page are sold without a prescription (over the counter).
- Is a store brand the same as the name brand?
- Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
- Has Aspirin, dextromethorphan, doxylamine and phenylephrine been recalled?
- No recall linked to these products appears in the FDA enforcement reports we use.
Drug Facts label
Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.
Alka-Seltzer Plus Cold Night · Bayer HealthCare LLC.
Aspirin 500 mg · Dextromethorphan hydrobromide 10 mg · Doxylamine succinate 6.25 mg · Phenylephrine bitartrate 7.8 mg, tablet, effervescent (oral)
Active ingredient (in each tablet)
Aspirin 500 mg (NSAID)* Dextromethorphan hydrobromide 10 mg Doxylamine succinate 6.25 mg Phenylephrine bitartrate 7.8 mg *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Uses
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
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.
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
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
Ask a doctor or pharmacist before use if
you are
- taking a prescription drug for
- gout
- diabetes
- arthritis
- taking sedatives or tranquilizers
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
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
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.
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 at bedtime (may be taken every 4 to 6 hours). Do not exceed 8 tablets in 24 hours or as directed by a doctor.
- children under 12 years: do not use
Other information
Other information
- each tablet contains: sodium 476 mg
- Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet
- store at room temperature. Avoid excessive heat.
Inactive ingredients
acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavors (natural & artificial), mannitol, povidone, sodium benzoate, sodium bicarbonate
Questions?
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)
— FDA label of Alka-Seltzer Plus Cold Night, Bayer HealthCare LLC., effective December 4, 2025. See the official label on DailyMed →
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz · Bayer HealthCare LLC.
Aspirin 325 mg · Dextromethorphan hydrobromide 10 mg · Doxylamine succinate 6.25 mg · Phenylephrine bitartrate 7.8 mg, tablet, effervescent (oral)
Active ingredient (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
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
- 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.
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
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
Ask a doctor or pharmacist before use if
you are taking a prescription drug for gout diabetes arthritis taking sedatives or tranquilizers
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
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
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.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
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 of age: do not use
Other information
- each tablet contains: potassium 78 mg; sodium 356 mg
- store at room temperature. Avoid excessive heat.
Inactive ingredients
anhydrous citric acid, calcium silicate, dimethicone, flavors, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose
Questions?
1-800-986-0369 (Mon-Fri 9AM - 5PM EST)
— FDA label of Alka-Seltzer Plus Severe Cold Night PowerFast Fizz, Bayer HealthCare LLC., effective January 8, 2026. See the official label on DailyMed →
This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.
Same medicine, other brands
Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.
Aspirin 500 mg · Dextromethorphan hydrobromide 10 mg · Doxylamine succinate 6.25 mg · Phenylephrine bitartrate 7.8 mg · tablet, effervescent (oral) · 2 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Alka-Seltzer Plus Cold Night | Bayer HealthCare LLC. | DailyMed |
| Alka-Seltzer Plus Severe Cold Powerfast Fizz Night | Bayer HealthCare LLC. | DailyMed |
Aspirin 325 mg · Dextromethorphan hydrobromide 10 mg · Doxylamine succinate 6.25 mg · Phenylephrine bitartrate 7.8 mg · tablet, effervescent (oral) · 1 product
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Alka-Seltzer Plus Severe Cold Night PowerFast Fizz | Bayer HealthCare LLC. | DailyMed |
Companies that sell this medicine
The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.
- Bayer HealthCare LLC.3 products
Recalls
No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- FDA rule for the Drug Facts label (21 CFR 201.66)
Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.