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|Sinarest No-Drowsiness Caplets

DECONGESTANTS AND ANALGESICS (Systemic)

Some commonly used brand names are:

In the U.S.—

• Actifed Sinus Daytime ²
• Actifed Sinus Daytime Caplets ²
• Advil Cold and Sinus ³
• Advil Cold and Sinus Caplets ³
• Allerest No-Drowsiness Caplets ²
• Coldrine ²
• Contac Allergy/Sinus Day Caplets ²
• Dristan Cold Caplets ²
• Dristan Sinus Caplets ²
• Motrin IB Sinus ³
• Motrin IB Sinus Caplets ³
• Ornex Maximum Strength Caplets ²
• PhenAPAP Without Drowsiness ²
• Sinarest No-Drowsiness Caplets ²
• Sine-Aid Maximum Strength ²
• Sine-Aid Maximum Strength Caplets ²
• Sine-Off Maximum Strength No Drowsiness Formula Caplets ²
• Sinus-Relief ²
• Sinutab Sinus Maximum Strength Without Drowsiness ²
• Sudafed Sinus Maximum Strength Without Drowsiness ²
• Sudafed Sinus Maximum Strength Without Drowsiness Caplets ²
• Tylenol Sinus Maximum Strength ²
• Tylenol Sinus Maximum Strength Caplets ²
• Tylenol Sinus Maximum Strength Gelcaps ²
• Tylenol Sinus Maximum Strength Geltabs ²

In Canada—

• Dristan N.D. Caplets ²
• Dristan N.D. Extra Strength Caplets ²
• Neo Citran Extra Strength Sinus ¹
• Sinutab No Drowsiness Caplets ²
• Sinutab No Drowsiness Extra Strength Caplets ²
• Sudafed Head Cold and Sinus Extra Strength Caplets ²
• Tylenol Sinus Medication Regular Strength Caplets ²
• Tylenol Sinus Medication Extra Strength Caplets ²

Category

• Decongestant-analgesic

Description

Decongestant and analgesic combinations are taken by mouth to relieve sinus and nasal congestion (stuffy nose) and headache of colds, allergy, and hay fever.

Decongestants, such as phenylephrine, and pseudoephedrine produce a narrowing of blood vessels. This leads to clearing of nasal congestion, but it may also cause an increase in blood pressure in patients who have high blood pressure.

Analgesics, such as acetaminophen, ibuprofen, and salicylates (e.g., aspirin, salicylamide), are used in these combination medicines to help relieve headache and sinus pain.

Acetaminophen and salicylates may cause kidney damage or cancer of the kidney or urinary bladder if large amounts of both medicines are taken together for a long time. However, taking the recommended amounts of combination medicines that contain both acetaminophen and a salicylate for short periods of time has not been shown to cause these unwanted effects.

These medicines are available without a prescription. However, your doctor may have special instructions on the proper dose of these medicines for your medical condition. They are available in the following dosage forms:

• Oral
• Phenylephrine and Acetaminophen
  • For oral solution (Canada)
• Pseudoephedrine and Acetaminophen
  • Capsules (U.S.)
  • Tablets (U.S. and Canada)
• Pseudoephedrine and Ibuprofen
  • Tablets (U.S. and Canada)

Before Using This Medicine

If you are taking this medicine without a prescription, carefully read and follow any precautions on the label. For decongestant and analgesic combinations, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to any of the ingredients contained in this medicine.

If this medicine contains aspirin, salicylamide , or ibuprofen , before taking it check with your doctor if you have ever had any unusual or allergic reaction to any of the following medicines:

• Aspirin or other salicylates
• Diclofenac (e.g., Voltaren)
• Diflunisal (e.g., Dolobid)
• Etodolac (e.g., Lodine)
• Fenoprofen (e.g., Nalfon)
• Floctafenine (e.g., Idarac)
• Flurbiprofen, by mouth (e.g., Ansaid)
• Ibuprofen (e.g., Motrin)
• Indomethacin (e.g., Indocin)
• Ketoprofen (e.g., Orudis)
• Ketorolac (e.g., Toradol)
• Meclofenamate (e.g., Meclomen)
• Mefenamic acid (e.g., Ponstel)
• Methyl salicylate (oil of wintergreen)
• Nabumetone (e.g., Relafen)
• Naproxen (e.g., Naprosyn)
• Oxaprozin (e.g., Daypro)
• Oxyphenbutazone (e.g., Tandearil)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Suprofen (e.g., Suprol)
• Tenoxicam (e.g., Mobiflex)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)
• Zomepirac (e.g., Zomax)

Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—The occasional use of decongestant and analgesic combinations at the doses recommended on the label is not likely to cause problems in the fetus or in the newborn baby. However, for the individual ingredients of these combinations, the following information applies:

• Alcohol —Some of these combination medicines contain large amounts of alcohol. Too much use of alcohol during pregnancy may cause birth defects.
• Caffeine —Studies in humans have not shown that caffeine causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to the amount of caffeine contained in 12 to 24 cups of coffee a day).
• Ibuprofen —Studies on birth defects have not been done in humans. However, there is a chance that ibuprofen may cause unwanted effects on the heart or blood flow of the fetus or newborn baby if it is taken regularly during the last few months of pregnancy.
• Phenylephrine —Studies on birth defects have not been done in either humans or animals with phenylephrine.
• Pseudoephedrine —Studies on birth defects with pseudoephedrine have not been done in humans. In animal studies pseudoephedrine did not cause birth defects. However, when given to animals in high doses, pseudoephedrine did cause a decrease in average weight, length, and rate of bone formation in the animal fetus.
• Salicylates (e.g., aspirin) —Studies on birth defects in humans have been done with aspirin, but not with salicylamide. Although salicylates have been shown to cause birth defects in animals, they have not been shown to cause birth defects in humans.
  Regular use of salicylates late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or newborn baby. Use of salicylates during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery, or in the newborn baby. Also, too much use of salicylates during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor and cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor .

Breast-feeding—If you are breast-feeding the chance that problems might occur depends on the ingredients of the combination. For the individual ingredients of these combinations, the following apply:

• Acetaminophen —Acetaminophen passes into the breast milk. However, it has not been reported to cause problems in nursing babies.
• Alcohol —Alcohol passes into the breast milk. However, the amount of alcohol in recommended doses of this medicine does not usually cause problems in nursing babies.
• Caffeine —Small amounts of caffeine pass into the breast milk and may build up in the nursing baby. However, the amount of caffeine in recommended doses of this medicine does not usually cause problems in nursing babies.
• Decongestants (e.g., phenylephrine, pseudoephedrine) —Decongestants may pass into the breast milk and may cause unwanted effects in nursing babies of mothers taking this medicine.
• Salicylates (e.g., aspirin, salicylamide) —Salicylates pass into the breast milk. Although salicylates have not been reported to cause problems in nursing babies, it is possible that problems may occur if large amounts are taken regularly.

Children—Very young children are usually more sensitive to the effects of this medicine. Before giving any of these combination medicines to a child, check the package label very carefully. Some of these medicines are too strong for use in children . If you are not certain whether a specific product can be given to a child, or if you have any questions about the amount to give, check with your health care professional, especially if it contains:

• Decongestants (e.g., phenylephrine, pseudoephedrine) —Increases in blood pressure may be more likely to occur in children taking decongestants.
• Salicylates (e.g., aspirin) — Do not give aspirin or other salicylates to a child with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child"s doctor . This is very important because salicylates may cause a serious illness called Reye"s syndrome in these children. Also, children may be more sensitive to the aspirin or other salicylates contained in some of these medicines, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating.

Adolescents—Do not give aspirin or other salicylates to a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child"s doctor . This is very important because salicylates may cause a serious illness called Reye"s syndrome in these individuals.

Older adults—The elderly are usually more sensitive to the effects of this medicine.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine, for example, aspirin or other medicine for allergies. Some medicines may change the way this medicine affects your body. Also, the effect of other medicines may be increased or reduced by some of the ingredients in this medicine. Check with your health care professional about which medicines you should not take together with this medicine.

Other medical problems—The presence of other medical problems may affect the use of decongestant and analgesic combinations. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse—Acetaminophen-containing medicine increases the chance of liver damage

• Anemia—Taking aspirin-, salicylamide-, or ibuprofen-containing medicine may make the anemia worse

• Asthma, allergies, and nasal polyps, history of—Taking salicylate- or ibuprofen-containing medicine may cause an allergic reaction in which breathing becomes difficult

• Diabetes mellitus (sugar diabetes)—The decongestant in this medicine may put the patient with diabetes at a greater risk of having heart or blood vessel disease

• Gout—Aspirin-containing medicine may make the gout worse and reduce the benefit of the medicines used for gout

• Hepatitis or other liver disease—Liver disease increases the chance of side effects because the medicine is not broken down and may build up in the body; also, if liver disease is severe there is a greater chance that aspirin-containing medicine may cause bleeding, and that ibuprofen-containing medicine may cause serious kidney damage

• Heart or blood vessel disease or
• High blood pressure—The decongestant in this medicine may cause the blood pressure to increase and may also speed up the heart rate; also, caffeine-containing medicine if taken in large amounts may increase the heart rate; ibuprofen-containing medicine may cause the blood pressure to increase

• Hemophilia or other bleeding problems—Aspirin- or ibuprofen-containing medicine increases the chance of bleeding

• Kidney disease—The kidneys may be affected, especially if too much of this medicine is taken for a long time

• Mental illness (history of)—The decongestant in this medicine may increase the chance of mental side effects

• Overactive thyroid—If an overactive thyroid has caused a fast heart rate, the decongestant in this medicine may cause the heart rate to speed up further

• Stomach ulcer or other stomach problems—Salicylate- or ibuprofen-containing medicine may make the ulcer worse or cause bleeding of the stomach

• Systemic lupus erythematosus (SLE)—Ibuprofen-containing medicine may put the patient with SLE at a greater risk of having unwanted effects on the central nervous system and/or kidneys

• Ulcers, sores, or white spots in the mouth—This may be a sign of a serious side effect of ibuprofen-containing medicine; if you already have ulcers or sores in the mouth you and your doctor may not be able to tell when this side effect occurs

Proper Use of This Medicine

Take this medicine only as directed . Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

For aspirin- or salicylamide-containing medicines :

• If this medicine irritates your stomach, you may take it with food or a glass of water or milk to lessen the irritation.
• If a combination medicine containing aspirin has a strong vinegar-like odor, do not use it . This odor means the medicine is breaking down. If you have any questions about this, check with your pharmacist.

For ibuprofen-containing medicines :

• To lessen stomach upset, these medicines may be taken with food or an antacid.
• Take with a full glass (8 ounces) of water. Also, do not lie down for about 15 to 30 minutes after taking the medicine. Doing so may cause irritation that may lead to trouble in swallowing.

Dosing—The dose of these combination medicines will be different for different products. Follow the directions on the box if you are buying this medicine without a prescription. Or, follow your doctor"s orders if this medicine was prescribed . The following information includes only the average doses for these combinations.

The number of capsules or tablets or teaspoonfuls of liquid that you take depends on the strengths of the medicines.

There is a large variety of decongestant and analgesic combination products on the market. Some products are for use in adults only, while others may be used in children. If you have any questions about this, check with your health care professional.

• For oral dosage forms (capsules, liquid, or tablets):
  • For sinus pain and congestion:
    • Adults and children 12 years of age and older: 1 to 2 capsules or tablets every four to six hours.
    • Children up to 6 years of age: Use and dose must be determined by your doctor.
    • Children 6 to 12 years of age: 1 tablet, 4 to 6 chewable tablets, or 1 to 2 teaspoonfuls of liquid every four hours.

Missed dose—If you must take this medicine regularly and you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep this medicine out of the reach of children. Overdose is very dangerous in young children.
• Store away from heat and direct light.
• Do not store the capsule or tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Check with your doctor if your symptoms do not improve or become worse, or if you have a high fever.

This medicine may cause some people to become nervous or restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of this medicine for each day a few hours before bedtime . If you have any questions about this, check with your doctor.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Check the label of all over-the-counter (OTC), nonprescription, and prescription medicines you now take . If any of them contain acetaminophen, aspirin, other salicylates such as bismuth subsalicylate (e.g., Pepto Bismol) or magnesium salicylate (e.g., Nuprin Backache Caplets), or salicylic acid (present in some shampoos and skin products), check with your health care professional. Using any of them together with this medicine may cause an overdose .

Do not drink alcoholic beverages while taking this medicine . Stomach problems may be more likely to occur if you drink alcoholic beverages while you are taking aspirin or ibuprofen. Also, liver damage may be more likely to occur if you drink large amounts of alcoholic beverages while you are taking acetaminophen.

If you think that you or anyone else may have taken an overdose of this medicine, get emergency help at once . Taking an overdose of a salicylate may cause unconsciousness or death. The first sign of an aspirin overdose may be ringing or buzzing in the ears. Other signs include convulsions (seizures), hearing loss, confusion, severe drowsiness or tiredness, severe excitement or nervousness, and unusually fast or deep breathing. Signs of severe acetaminophen overdose may not appear until 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started within 24 hours or less after the overdose is taken.

For patients taking aspirin-containing medicine :

• Do not take aspirin-containing medicine for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.

For diabetic patients taking salicylate-containing medicine :

• False urine sugar test results may occur if you take 8 or more 325-mg (5-grain) doses of aspirin every day for several days in a row. Smaller doses or occasional use of aspirin usually will not affect urine sugar tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.

For patients taking ibuprofen-containing medicine :

• This medicine may cause some people to become confused, drowsy, dizzy, lightheaded, or less alert than they are normally. It may also cause blurred vision or other vision problems in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and able to see well .
• Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although serious side effects occur rarely when this medicine is taken as recommended, they may be more likely to occur if:

• Too much medicine is taken
• It is taken in large doses
• It is taken for a long period of time

Get emergency help immediately if any of the following symptoms of overdose occur :

Also, check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. There are some similarities among these combination medicines, so many of the above side effects may occur with any of these medicines.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 08/04/2005

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