This combination product contains 2 medications, acetaminophen and an antihistamine. Acetaminophen helps to reduce fever and/or mild to moderate pain (such as headache, backache, aches/pains due to muscle strain, cold, or flu). The antihistamine in this product may cause drowsiness, so it can also be used as a nighttime sleep aid. Antihistamines can also be used to help relieve allergy or cold symptoms such as watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

See also Warning section.

If you are taking an over-the-counter product, read all directions on the product package before taking this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, take it as directed.

Take this medication by mouth with or without food or as directed by your doctor. If stomach upset occurs, you may take this medication with food or milk.

If you are using the liquid form, carefully measure your prescribed dose using a medication-measuring device or spoon. Do not use a household spoon because you may not get the correct dose.

If you are using the powder form, follow the instructions on the product package. Some brands should be dissolved in water before swallowing.

If you are taking extended-release capsules, swallow them whole. Do not crush or chew extended-release capsules or tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

The dosage is based on your medical condition and response to treatment. Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

Do not take this product for pain more than 10 days (adults) or 5 days (children) unless directed by a doctor. Do not take this product for fever more than 3 days unless directed by your doctor. If your condition lasts or gets worse, or if you think you may have a serious medical problem, get medical help right away.

See also Warning section.

Dizziness, drowsiness, constipation, stomach upset, blurred vision, or dry mouth/nose/throat may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

If your doctor has prescribed this medication, remember that 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)
• trouble urinating

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.

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen or antihistamines; 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, chronic obstructive pulmonary disease-COPD)
• glaucoma
• heart disease
• high blood pressure
• liver disease
• stomach/intestinal problems (such as blockage, constipation, ulcers)
• overactive thyroid gland (hyperthyroidism)
• urination problems (such as trouble urinating due to enlarged prostate, 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).

Liquid and powder products may contain alcohol, sugar, and/or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Some brands of this medication contain sodium. Ask your doctor or pharmacist for more information if you are on a salt-restricted diet or if you have a condition that could be worsened by an increase in salt intake.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of antihistamines. In young children, this drug may cause agitation and excitement instead of drowsiness.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, drowsiness, confusion, constipation, or trouble urinating. Dizziness, drowsiness, and confusion can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

See also Warning section.

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 are:

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

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).

Antihistamines are ingredients found in many nonprescription products and in some combination prescription medications. Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may also contain an antihistamine or other ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain medical/lab tests (such as urine 5-HIAA, allergy skin 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: nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, agitation, confusion, flushing, hallucinations, yellowing eyes/skin, dark urine, seizures. In children, excitement may occur first, and may be followed by: loss of coordination, drowsiness, loss of consciousness, seizures.

If your doctor has prescribed this medication, do not share it with others.

Keep all medical and lab appointments.

If you are taking this product on a regular schedule and 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. Do not freeze liquid forms of this product. 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.