Diphenhydramine Hydrochloride, Magnesium Salicylate Tetrahydrate Oral tablet

What is this medicine?

DIPHENHYDRAMINE, MAGNESIUM SALICYLATE (dye fen HYE dra meen; mag NEE zhum sa LI si late) is a combination of a sleep aid and a pain reliever. It is used to treat patients with minor backaches that have trouble sleeping.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding problems
• breathing problem like emphysema, chronic bronchitis
• child with chickenpox, the flu, or other viral infection
• diabetes
• glaucoma
• gout
• heart disease, failure
• high blood pressure
• if you frequently drink alcohol containing drinks
• kidney disease
• liver disease
• smoke tobacco
• stomach ulcers or other problems
• thyroid problems
• trouble passing urine
• an unusual or allergic reaction to magnesium salicylate, aspirin, other medicines, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the package or prescription label. You can take this medicine with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• methotrexate
• probenecid
• other medicines with diphenhydramine

This medicine may also interact with the following medications:

• acetazolamide
• alcohol
• antibiotics like ciprofloxacin, levofloxacin, ofloxacin, tetracycline
• aspirin and aspirin-like medicines
• bismuth subsalicylate
• cidofovir
• flavocoxid
• herbal supplements like feverfew, garlic, ginger, ginkgo biloba, horse chestnut
• medicines for arthritis
• medicines for diabetes
• medicines for gout
• medicines that treat or prevent blood clots like enoxaparin, heparin, ticlopidine, warfarin
• methazolamide
• other medicines for sleep
• sulfinpyrazone
• varicella live vaccine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if the pain lasts more than 10 days, if it gets worse, or if there is a new or different kind of pain. Tell your doctor if you see redness or swelling. Also, check with your doctor if a fever that lasts for more than 3 days.

Do not take other diphenhydramine, aspirin or aspirin-like medicines with this medicine. Too much medicine can be dangerous. Always read the labels carefully.

This medicine can irritate your stomach or cause bleeding problems. Do not smoke cigarettes or drink alcohol while taking this medicine. Do not lie down for 30 minutes after taking this medicine to prevent irritation to your throat.

If you are scheduled for any medical or dental procedure, tell your healthcare provider that you are taking this medicine. You may need to stop taking this medicine before the procedure.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• black, tarry stools
• bloody, coffee ground-like vomit
• breathing problems
• changes in hearing, ringing in the ears
• confusion
• pain on swallowing
• trouble passing urine or change in the amount of urine
• unusual bleeding, bruising
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea or constipation
• nausea, vomiting
• stomach gas, heartburn

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from heat and moisture. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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.