Voluntary Recall

of Alka-Seltzer Plus® Products Due to a Labeling Error
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Bayer OTC
  • Severe Sinus Congestion Day & Night Liquid Gels
    Use as directed

alka-seltzer plus maximum strength severe sinus congestion & cough day & night liquid gels

Maybe it starts with the sniffles, a headache and a little sinus pressure. Before you know it, you're battling multiple symptoms during the day and not getting the rest you need at night. Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion & Cough Day & Night Liquid Gels deliver:
  • Daytime cough medicine and other active ingredients for relief from:
    • Nasal & Sinus Congestion
    • Sinus Pressure
    • Headache
    • Body Ache
    • Cough
  • Nighttime decongestant and other active ingredients for relief from:
    • Headache & Pain
    • Runny Nose
    • Sneezing
    • Nasal & Sinus Congestion
    • Sinus Pressure
    • Cough
... all in one convenient package!
Maximum Strength Per 4-Hour Dosing.
 
DRUG FACTS

What you should know about this product

Do not take these products at the same time.

Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Day Liquid Gels

USES
  • Temporarily relieves these symptoms due to a cold or flu:
    • Nasal congestion
    • Sinus congestion and pressure
    • Minor aches and pains
    • Headache
    • Cough
    • Sore throat
  • helps clear nasal passages and shrinks swollen membranes
  • Temporarily reduces fever
 
DIRECTIONS
  • Do not take more than the recommended dose
  • Adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
  • Children under 12 years: do not use
 

Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Night Liquid Gels

USES
  • Temporarily relieves these symptoms due to a cold or flu:
    • Nasal congestion
    • Sinus congestion and pressure
    • Minor aches and pains
    • Headache
    • Cough
    • Sore throat
    • Runny nose
    • Sneezing
  • Temporarily reduces fever
 
DIRECTIONS
  • Do not take more than the recommended dose
  • Adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules 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® Maximum Strength Severe Sinus Congestion & Cough Day Liquid Gels

USES
  • Temporarily relieves these symptoms due to a cold or flu:
    • Nasal congestion
    • Sinus congestion and pressure
    • Minor aches and pains
    • Headache
    • Cough
    • Sore throat
  • helps clear nasal passages and shrinks swollen membranes
  • Temporarily reduces fever
 
DIRECTIONS
  • Do not take more than the recommended dose
  • Adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
  • Children under 12 years: do not use
 

Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Night Liquid Gels

USES
  • Temporarily relieves these symptoms due to a cold or flu:
    • Nasal congestion
    • Sinus congestion and pressure
    • Minor aches and pains
    • Headache
    • Cough
    • Sore throat
    • Runny nose
    • Sneezing
  • Temporarily reduces fever
 
DIRECTIONS
  • Do not take more than the recommended dose
  • Adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
  • Children under 12 years: do not use
 

Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Day Liquid Gels

ACTIVE INGREDIENTS
  • Acetaminophen 325 mg (Pain reliever/Fever reducer)
  • Dextromethorphan Hydrobromide 10 mg (Cough suppressant)
  • Phenylephrine Hydrochloride 5 mg (Nasal decongestant)
 

Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Night Liquid Gels

ACTIVE INGREDIENTS
  • Acetaminophen 325 mg (Pain reliever/Fever reducer)
  • Dextromethorphan Hydrobromide 10 mg (Cough suppressant)
  • Doxylamine Succinate 6.25 mg (Antihistamine)
  • Phenylephrine Hydrochloride 5 mg (Nasal decongestant)
 

INACTIVE INGREDIENTS

Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Day Liquid Gels

  • FD&C yellow #6, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Night Liquid Gels

  • FD&C blue #1, D&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide
WARNINGS

Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Day Liquid Gels

LIVER WARNING:
This product contains acetaminophen. Severe liver damage may occur if you take
  • More than 4,000 mg of acetaminophen in 24 hours
  • With other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
ALLERGY ALERT:
Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
  • Skin reddening
  • Blisters
  • Rash
  • Hives
  • Facial swelling
  • Asthma (wheezing)
  • Shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
 
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
  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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 you have
  • Liver disease
  • Heart disease
  • High blood pressure
  • 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

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

Stop use and ask a doctor if
  • 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.
  • Nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Night Liquid Gels

LIVER WARNING:
This product contains acetaminophen. Severe liver damage may occur if you take
  • More than 4,000 mg of acetaminophen in 24 hours
  • With other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
ALLERGY ALERT:
Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
  • Skin reddening
  • Blisters
  • Rash
  • Hives
  • Facial swelling
  • Asthma (wheezing)
  • Shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
 
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
  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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 you have
  • Liver disease
  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • 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

Ask a doctor or pharmacist before use if you are

  • Taking the blood thinning drug warfarin
  • 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
  • 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.
  • Nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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