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Over-the-counter medicine · no prescription needed

Aspirin, dextromethorphan and phenylephrine

Cough, cold and flu

Official FDA data, not advice

The label text is quoted exactly as the company filed it with the U.S. Food and Drug Administration (FDA), with a link to the official copy. The list of brands comes from the FDA NDC Directory.

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.

If someone may have taken too much, call Poison Help: 1‑800‑222‑1222. In an emergency, call 911.

Quick answers

What is Aspirin, dextromethorphan and phenylephrine used for?
The Drug Facts label of Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy (Bayer HealthCare LLC.) lists these uses: Uses · temporarily relieves these symptoms due to a cold with cough: · minor aches and pains · headache · cough · nasal and sinus congestion · sore throat · temporarily reduces fever.
Do I need a prescription for Aspirin, dextromethorphan 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 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 Severe Cold PowerFast Fizz Non Drowsy · Bayer HealthCare LLC.

Aspirin 325 mg · Dextromethorphan hydrobromide 10 mg · Phenylephrine bitartrate 7.8 mg, tablet, effervescent (oral)

Active ingredient

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

Uses

Uses · temporarily relieves these symptoms due to a cold with cough: · minor aches and pains · headache · cough · nasal and sinus congestion · sore throat · temporarily reduces fever

Warnings

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

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

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 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 Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if

you are · taking a prescription drug for · gout · diabetes · arthritis

When using this product

When using this product

do not exceed recommended dosage 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 Pregnant or breast feeding

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

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 information

Other information

  • each tablet contains : potassium 80 mg; sodium 356 mg
  • store at room temperature. Avoid excessive heat.

Inactive ingredients

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Questions?

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM – 5PM EST)

— FDA label of Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy, Bayer HealthCare LLC., effective January 8, 2026. See the official label on DailyMed →

ALKA SELTZER PLUS Cold Day and Night Effervescent · Sincronia Logistica, S.A. de C.V.

Aspirin 325 mg · Dextromethorphan hydrobromide 10 mg · Phenylephrine bitartrate 7.8 mg, tablet (oral)

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)* Dextromethorphan hydrobromide 10 mg Phenylephrine bitartrate 7.8 mg *nonsteroidal anti-inflammatory drug Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

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

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.

  • Reye’s syndrome: Aspirin may cause a severe allergic reaction which may include:
  • Allergy alert:
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
  • Stomach bleeding warning:
  • 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 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. Sore throat warning

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
  • thyroid disease
  • diabetes
  • 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
  • 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 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

sodium 476 mg

  • Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet
  • each tablet contains:
  • 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?

1-800-986-0369

— FDA label of ALKA SELTZER PLUS Cold Day and Night Effervescent, Sincronia Logistica, S.A. de C.V., effective October 23, 2023. 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 325 mg · Dextromethorphan hydrobromide 10 mg · Phenylephrine bitartrate 7.8 mg · tablet, effervescent (oral) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy Bayer HealthCare LLC. DailyMed
Aspirin 325 mg · Dextromethorphan hydrobromide 10 mg · Phenylephrine bitartrate 7.8 mg · tablet (oral) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
ALKA SELTZER PLUS Cold Day and Night Effervescent Sincronia Logistica, S.A. de C.V. 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.1 product
  • Sincronia Logistica, S.A. de C.V.1 product

Recalls

No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. 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.

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