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Generic Name: aspirin/diphenhydramine/phenylpropanolamine (AS pir in/dye fen HYE dra meen/fen ill proe pa NOLE a meen)
Brand Names: Alka Seltzer Plus Night Time Effervescent

What is Alka Seltzer Plus Night Time Effervescent (aspirin/diphenhydramine/phenylpropanolamine)?

Aspirin is in a class of drugs called salicylates. Aspirin is a pain reliever, an anti-inflammatory, and a fever reducer. It is used to treat many conditions, such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Diphenhydramine is an antihistamine. It blocks the naturally occurring chemical histamine in the body. Diphenhydramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces blood flow to affected areas and allows nasal passages to open up.

The combination, aspirin/diphenhydramine/phenylpropanolamine, is used to treat nasal congestion, sinusitis (inflammation of the sinuses), headache, fever, and aches and pains associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Aspirin/diphenhydramine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Alka Seltzer Plus Night Time Effervescent (aspirin/diphenhydramine/phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Do not take more of this medication than is directed. Consult your doctor if you symptoms are not being relieved.

Who should not take Alka Seltzer Plus Night Time Effervescent (aspirin/diphenhydramine/phenylpropanolamine)?

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day. Alcohol can cause stomach bleeding when it is combined with any medicine that contains aspirin.

Before taking this medication, tell your doctor if you have

• an ulcer or a bleeding or coagulation disorder,

• kidney disease,
• liver disease,

• diabetes,

• glaucoma,

• any type of heart disease or high blood pressure,

• thyroid disease,

• emphysema or chronic bronchitis, or

• difficulty urinating or an enlarged prostate.

You may not be able to take aspirin/diphenhydramine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

How should I take Alka Seltzer Plus Night Time Effervescent (aspirin/diphenhydramine/phenylpropanolamine)?

Take aspirin/diphenhydramine/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse or doctor to explain them to you.

Do not take aspirin/diphenhydramine/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, see your doctor.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Symptoms of an aspirin/diphenhydramine/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, ringing in the ears, dizziness, hallucinations, seizures, rapid breathing, nausea, and vomiting.

What should I avoid while taking Alka Seltzer Plus Night Time Effervescent (aspirin/diphenhydramine/phenylpropanolamine)?

Aspirin/diphenhydramine/dextromethorphan/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if aspirin/diphenhydramine/phenylpropanolamine is taken with any of these medications.

Be aware of the aspirin content of other over-the-counter and prescription products. Any aspirin content in these products counts toward your total daily dose.

What are the possible side effects of aspirin/diphenhydramine/ phenylpropanolamine?

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• black, bloody, or tarry stools;

• blood in vomit or urine;

• nausea, vomiting, or abdominal pain;

• uncontrolled fever;

• seizures;

• an irregular heartbeat; or

• abnormal behavior, hallucinations, or paranoia.

Other, less serious side effects may be more likely to occur. Continue to take aspirin/diphenhydramine/phenylpropanolamine and talk to your doctor, or try another similar medication if you experience

• dryness of the eyes, nose, and mouth;

• drowsiness, lightheadedness, dizziness, or weakness;

• headache;

• faint ringing in the ears;

• upset stomach or indigestion;

• blurred vision;

• restlessness, tremor, insomnia, or anxiety;

• sweating;

• difficulty urinating; or

• excitation in children.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Alka Seltzer Plus Night Time Effervescent (aspirin/diphenhydramine/phenylpropanolamine)?

Do not take other over-the-counter cough, cold, allergy, diet, fever, pain, or sleep aids while taking aspirin/diphenhydramine/phenylpropanolamine unless your pharmacist or doctor approves. Other medications may also contain aspirin, diphenhydramine, phenylpropanolamine, or other similar drugs, and you may accidentally take too much and harm yourself.

Aspirin/diphenhydramine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if aspirin/diphenhydramine/phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with aspirin/diphenhydramine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist has additional information about aspirin/diphenhydramine/ phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Aspirin/diphenhydramine/phenylpropanolamine is available over the counter under the brand name Night Time Effervescent Cold Tablets. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.