Voluntary Recall

of Alka-Seltzer Plus® Products Due to a Labeling Error
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Bayer OTC
  • Cold Day & Night Effervescent Tablets
    Use as directed

alka-seltzer plus multi-symptom cold day & night effervescent tablets

The legendary effervescence of Alka-Seltzer Plus has been helping people tackle their cold symptoms since 1968. We've harnessed that same fast-dissolving power with Alka-Seltzer Plus day & night cold medicine to deliver around-the-clock relief from:
  • Day:
    • Sore Throat
    • Sinus Pressure
    • Fever
    • Nasal Congestion
    • Headache & Body Ache
    • Cough
  • Night:
    • Runny Nose
    • Sore Throat
    • Fever
    • Nasal Congestion
    • Headache & Body Ache
    • Cough
 
DRUG FACTS

What you should know about this product

Do not take these products at the same time.

Alka-Seltzer Plus® Multi-Symptom Cold Day Effervescent Tablets

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
 
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
 

Alka-Seltzer Plus® Multi-symptom Cold Night Effervescent Tablets

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
 
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
DOWNLOAD DRUG FACTS PDF

The Drug Facts labeling information on this website may differ from the product labeling on purchased product.
Please consult your purchased package for information specific to that product.
DRUG FACTS

What you should know
about this product

Do not take these products at the same time.

Alka-Seltzer Plus® Multi-Symptom Cold Day Effervescent Tablets

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
 
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
 

Alka-Seltzer Plus® Multi-symptom Cold Night Effervescent Tablets

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
 
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
 

Alka-Seltzer Plus® Multi-Symptom Cold Day Effervescent Tablets

ACTIVE INGREDIENTS
  • 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
 

Alka-Seltzer Plus® Multi-Symptom Cold Night Effervescent Tablets

ACTIVE INGREDIENTS
  • Aspirin 500 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
 

INACTIVE INGREDIENTS

Alka-Seltzer Plus® Multi-Symptom Cold Day Effervescent Tablets

  • acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Alka-Seltzer Plus® Multi-Symptom Cold Night Effervescent Tablets

  • acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavors (natural & artificial), mannitol, povidone, sodium benzoate, sodium bicarbonate
WARNINGS

Alka-Seltzer Plus® Multi-Symptom Cold Day Effervescent Tablets

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
  • 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)
    • 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

When using this product do not exceed recommended dosage

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.

Alka-Seltzer Plus® Multi-Symptom Cold Night Effervescent Tablets

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.

The Drug Facts labeling information on this website may differ from the product labeling on purchased product.
Please consult your purchased package for information specific to that product.
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Voluntary Recall

of Alka-Seltzer Plus® Products
Due to a Labeling Error
Click here for details