When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to acetaminophen (Tylenol®), or to diphenhydramine (Benadryl®). Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years old. Using these medicines in very young children might cause serious or possibly life-threatening side effects.

How to Use This Medicine:
Capsule, Tablet, Packet, Liquid

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine contains acetaminophen. Read the labels of all other medicines you are using to see if they also contain acetaminophen, or ask your doctor or pharmacist. Do not use more than 4 grams (4,000 milligrams) total of acetaminophen in one day.
• Follow the instructions on the medicine label if you are using this medicine without a prescription.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Place the oral powder on your tongue, and then take a drink of water or another liquid. You may also put the powder into a glass of water or other liquid, stir it, and then drink it.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not also use other medicines that contain acetaminophen or diphenhydramine, including topical (skin) medicine. You may be getting more than a safe amount of these medicines.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine. Acetaminophen taken with alcohol can increase your risk of damage to your liver. If you regularly drink three or more alcoholic drinks every day, do not take any medicines that contain acetaminophen without asking your doctor.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breast feeding, or if you have glaucoma, kidney problems, or liver problems. Tell your doctor if you have a history of breathing problems such as asthma or COPD (emphysema or chronic bronchitis). Make sure your doctor knows if you have trouble urinating due to an enlarged prostate gland. Tell your doctor if you drink alcohol on a regular basis. Make sure your doctor knows if you have had an allergic reaction to any antihistamine, and about any other health problems you may have.
• Do not give this medicine to anyone under 12 years of age, unless a doctor tells you to.
• This medicine may make you drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Do not use this medicine for more than 10 days. Do not use this medicine to treat fever for more than 3 days, unless a doctor tells you to do so. If you have trouble sleeping that lasts for longer than 2 weeks, stop using this medicine and talk to your doctor.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Redness or swelling.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088