FDA records indicate that there are no current recalls for this drug.
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Excedrin Pm Triple Action Caplets Recall
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Questions & Answers
Side Effects & Adverse Reactions
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: Acetaminophen may cause severe skin reactions. Symptoms may include:
● skin reddening ● blisters ● rash
If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
● hives ● facial swelling ● asthma (wheezing) ● shock
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
● more than 2 caplets in 24 hours, which is the maximum daily amount
● with other drugs containing acetaminophen
● 3 or more alcoholic drinks every day while using this product
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
● if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
● with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
● with any other product containing diphenhydramine, even one used on skin
● in children under 12 years of age
● you have liver disease
● 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
● you have glaucoma
● you have a breathing problem such as emphysema or chronic bronchitis
● you have trouble urinating due to an enlarged prostate gland
● a prescription drug for:
● diabetes
● gout
● arthritis
● any other drug, or are under a doctor’s care for any serious condition
● any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
● sedatives or tranquilizers
● drowsiness will occur
● avoid alcoholic drinks
● do not drive a motor vehicle or operate 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
● sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
● pain gets worse or last for more than 10 days
● painful area is red or swollen
● ringing in the ears or a loss of hearing occurs
● any new symptoms occur
These could be signs of a serious condition
ask a health professional before use. It is especially important not to use aspirin during the last three 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.
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.
● if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
● with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
● with any other product containing diphenhydramine, even one used on skin
● in children under 12 years of age
Ask a doctor before use if● you have liver disease
● 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
● you have glaucoma
● you have a breathing problem such as emphysema or chronic bronchitis
● you have trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking● a prescription drug for:
● diabetes
● gout
● arthritis
● any other drug, or are under a doctor’s care for any serious condition
● any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
● sedatives or tranquilizers
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
● sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
● pain gets worse or last for more than 10 days
● painful area is red or swollen
● ringing in the ears or a loss of hearing occurs
● any new symptoms occur
These could be signs of a serious condition
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
● for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Excedrin Pm Triple Action Caplets Manufacturers
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Novartis Consumer Health, Inc.
Excedrin Pm Triple Action Caplets | Novartis Consumer Health, Inc.
● do not use more than directed
● do not use in children under 12 years of age
● adults and children 12 years of age and over: take 2 caplets at bedtime, with a full glass of water
● do not take more than 2 caplets in 24 hours, unless directed by a doctor
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