Acetaminophen/Antihistamine – Oral

Medication Uses How To Use Side Effects Precautions Drug Interactions Overdose Notes Missed Dose Storage

USES: This combination product contains acetaminophen and an antihistamine. Acetaminophen reduces fever and mild to moderate pain (such as headache, backache, muscle strain, cold, or flu). The antihistamine in this product may cause drowsiness and can also be used as a nighttime sleep aid. Antihistamines can also relieve allergy or cold symptoms such as watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Cough-and-cold products are not safe or effective for children under 6 years old. Do not use this product to treat cold symptoms in children under 6 years old unless directed by a doctor. Some long-acting tablets/capsules are not recommended for children under 12 years old. Ask your doctor or pharmacist for more details on using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. Follow all dosage directions to decrease the risk of serious side effects. 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. Ask the doctor or pharmacist for other ways to relieve cough and cold symptoms.
HOW TO USE: If you are taking an over-the-counter product, read all directions on the 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. If you are using sustained-release tablets or capsules, swallow the medication whole. Do not crush, chew, or break the tablets or capsules. The dosage is based on your medical condition and response to treatment. Pain medications work best if used at the first signs of pain. Do not exceed the recommended dose of acetaminophen. Do not use this product for pain for more than 10 days (adults) or 5 days (children) unless directed by a doctor. Do not use this product for fever for more than 3 days unless directed by your doctor. If your condition persists or worsens, or if you think you may have a serious medical problem, seek immediate medical attention.
SIDE EFFECTS: Dizziness, drowsiness, constipation, stomach upset, blurred vision, or dry mouth/nose/throat may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, trouble urinating. In adults without liver problems, the maximum daily dose of acetaminophen is 4 grams. Taking more than the maximum daily amount may cause serious liver disease. Seek immediate medical attention if you have symptoms of liver damage. A serious allergic reaction to this drug is rare. Seek immediate medical attention if you notice any symptoms of a serious allergic reaction. This is not a complete list of possible side effects. Contact your doctor or pharmacist if you notice other effects not listed above. In the US, call your doctor for medical advice about side effects. You may report side effects to the FDA. In Canada, call your doctor for medical advice about side effects. You may report side effects to Health Canada.
PRECAUTIONS: Tell your doctor or pharmacist if you are allergic to acetaminophen or antihistamines, or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems, glaucoma, heart disease, high blood pressure, liver disease, stomach/intestinal problems, overactive thyroid gland, urination problems. This drug may make you dizzy or drowsy or cause blurred vision. Do not drive or operate machinery until you are sure you can do so safely. Limit alcohol consumption. Consult your doctor before using this drug in children. Older adults may be more sensitive to the effects of this drug. This medication should be used during the first 6 months of pregnancy only if clearly needed. It should not be used during the last 3 months of pregnancy due to the risk of serious side effects in a newborn baby. Discuss the risks and benefits with your doctor. This drug may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breastfeeding is not recommended while using this drug.

QUESTION

DRUG INTERACTIONS: If you are taking this medication under your doctor’s direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Before using this product, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use. Tell your doctor or pharmacist if you are taking other products that cause drowsiness. Acetaminophen and antihistamines are ingredients found in many nonprescription products and combination prescription medications. Check the labels of all your medicines. This medication may interfere with certain medical/laboratory tests. Make sure all your doctors know you use this drug. This document does not contain all possible interactions. Before using this product, tell your doctor or pharmacist of all the products you use.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: nausea, severe stomach pain, mental/mood changes.
NOTES: If your doctor has prescribed this medication, do not share it with others. Keep all regular medical and laboratory appointments. Do not take this product for several days before allergy testing.
MISSSED DOSE: 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 and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: 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 medicines away from children and pets. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details on how to safely discard your product.

Report Problems to the FDA

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement the expertise and judgment of healthcare professionals. The information is not intended to cover all uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet, or commencing or discontinuing any course of treatment.