This combination medication (doxylamine with pyridoxine) is used to prevent or reduce nausea and vomiting caused by pregnancy. Decreasing nausea and vomiting may improve your health and nutrition during pregnancy. Doxylamine is an antihistamine that is thought to work by affecting certain natural substances (acetylcholine, serotonin) in your body or by acting directly on certain parts of the brain. Pyridoxine is a B vitamin that is important for good health. Most people get enough pyridoxine in their diet, but certain health conditions (such as pregnancy, poor diet, alcoholism) can result in a lack of this vitamin.

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth without food as directed by your doctor. If this medication is taken with food, it may take longer for it to start to work but will not decrease the effect.

Swallow the medication whole with a full glass of water. Do not crush, chew, or break the tablets.

Dosage is based on your medical condition and response to treatment. This medication is usually taken at bedtime to decrease nausea and vomiting in the morning. If nausea lasts during the day, additional doses may be prescribed by your doctor. Talk with your doctor about your symptoms and the best dose schedule for you. Do not take more than 4 tablets in a day.

Do not stop using this medication or change your dose without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Drowsiness, dizziness, blurred vision, stomach upset, diarrhea, constipation, headache, and trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as confusion, irritability, nervousness)
• trouble urinating
• easy bruising/bleeding
• fast/irregular heartbeat

Get medical help right away if you have any very serious side effects, including:

• seizure

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this product, tell your doctor or pharmacist if you are allergic to doxylamine or pyridoxine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• breathing problems (such as asthma, emphysema)
• eye problems (such as glaucoma)
• heart problems
• liver disease
• seizures
• stomach problems (such as ulcers, blockage)
• urination problems (such as urinary retention)

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This product is safe to use during pregnancy.

Pyridoxine passes into breast milk. It is unknown if doxylamine passes into breast milk. However, similar drugs pass into breast milk. Doxylamine may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• altretamine
• antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray)

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain lab tests (such as urine drug screening tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: flushing, hallucinations, weakness, shaking (tremor), muscle twitching, loss of consciousness, seizures.

Do not share this medication with others.

Do not take for several days before allergy testing because test results can be affected.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.