FDA records indicate that there are no current recalls for this drug.
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Alka-seltzer Plus Cold Formula Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
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
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
- 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
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- a sodium-restricted diet
- taking a prescription drug for
- gout
- diabetes
- arthritis
- taking sedatives or tranquilizers
- do not exceed recommended dosage
- excitability may occur, especially in children
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- 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 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
- nervousness, dizziness, or sleeplessness occur
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.
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
- 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
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- a sodium-restricted diet
- taking a prescription drug for
- gout
- diabetes
- arthritis
- taking sedatives or tranquilizers
- 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 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
- nervousness, dizziness, or sleeplessness occur
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- headache
- runny nose
- nasal and sinus congestion
- sneezing
- sore throat
- temporarily reduces fever
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Alka-seltzer Plus Cold Formula Manufacturers
-
Bayer Healthcare Consumer Care
-
Bayer Healthcare Consumer Care
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