ANTIHISTAMINES,DECONGESTANTS, AND ANALGESICS (Systemic)

Some commonly used brand names are:

In the U.S.?

• Actifed Cold & Sinus Caplets ³
• Alka-Seltzer Plus Cold Medicine Liqui-Gels ³
• Benadryl Allergy/Sinus Headache Caplets ⁶
• Children's Tylenol Cold Multi-Symptom ³
• Comtrex Allergy-Sinus ³
• Comtrex Allergy-Sinus Caplets ³
• Contac Allergy/Sinus Night Caplets ⁶
• Dimetapp Cold & Fever Suspension ¹
• Dristan Cold Multi-Symptom Formula ²
• Drixoral Allergy-Sinus ⁵
• Drixoral Cold and Flu ⁵
• Kolephrin Caplets ³
• ND-Gesic ⁴
• Scot-Tussin Original 5-Action Cold Formula ⁸
• Sinarest ³
• Sine-Off Sinus Medicine Caplets ³
• Singlet for Adults ³
• TheraFlu/Flu and Cold Medicine ³
• TheraFlu/Flu and Cold Medicine for Sore Throat ³
• Tylenol Allergy Sinus Medication Maximum StrengthCaplets ³
• Tylenol Allergy Sinus Medication Maximum StrengthGelcaps ³
• Tylenol Allergy Sinus Medication Maximum StrengthGeltabs ³
• Tylenol Allergy Sinus Night Time Medicine MaximumStrength Caplets ⁶
• Tylenol Flu NightTime Hot Medication Maximum Strength ⁶
• Tylenol Flu NightTime Medication Maximum StrengthGelcaps ⁶

In Canada?

• Actifed Plus Extra Strength Caplets ¹⁰
• Dristan ²
• Dristan Extra Strength Caplets ²
• Neo Citran Nutrasweet ⁷
• Neo Citran Extra Strength Colds and Flu ⁷
• Sinutab Extra Strength Caplets ³
• Sinutab Regular Caplets ³
• Tylenol Allergy Sinus Medication Extra Strength Caplets ³
• Tylenol Cold Medication Children's ³
• Tylenol Flu NightTimeMedication Extra Strength Gelcaps ⁶

Category

• Antihistaminic (H ₁-receptor)-decongestant-analgesic?Brompheniramine, Pseudoephedrine, and Acetaminophen; Chlorpheniramine, Phenylephrine, andAcetaminophen; Chlorpheniramine, Pseudoephedrine,and Acetaminophen; Chlorpheniramine, Pyrilamine,Phenylephrine, and Acetaminophen; Dexbrompheniramine,Pseudoephedrine, and Acetaminophen; Diphenhydramine,Pseudoephedrine, and Acetaminophen; Pheniramine,Phenylephrine, and Acetaminophen; Pheniramine,Phenylephrine, Sodium Salicylate, and Caffeine; Pyrilamine, Phenylephrine, Aspirin, and Caffeine; Triprolidine, Pseudoephedrine, and Acetaminophen

Description

Antihistamine, decongestant,and analgesic combinations are taken by mouth to relieve the sneezing, runnynose, sinus and nasal congestion (stuffy nose), fever, headache, and achesand pain of colds, influenza, and hay fever. These combinations do not containany ingredient to relieve coughs.

Antihistamines are used to relieve or prevent the symptoms of hay feverand other types of allergy. They may also help relieve some symptoms of thecommon cold, such as sneezing and runny nose. They work by preventing theeffects of a substance called histamine, which is produced by the body. Antihistaminescontained in these combinations are:

brompheniramine, chlorpheniramine, dexbrompheniramine, diphenhydramine,pheniramine, phenyltoloxamine, pyrilamine, and triprolidine.

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

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

Some of these medicines are available without a prescription. However,your doctor may have special instructions on the proper dose of these medicinesfor your medical condition. These medicines are available in the followingdosage forms:

Oral
• Brompheniramine, Pseudoephedrine, and Acetaminophen
  • Oral suspension (U.S.)
  • Tablets (U.S.)
• Chlorpheniramine, Phenylephrine, and Acetaminophen
  • Capsules (Canada)
  • Tablets (U.S. and Canada)
  • Extended-release tablets (U.S.)
• Chlorpheniramine, Pseudoephedrine, and Acetaminophen
  • Capsules (U.S. and Canada)
  • For oral solution (U.S.)
  • Oral solution (U.S. and Canada)
  • Tablets (U.S. and Canada)
  • Chewable tablets (U.S. and Canada)
• Chlorpheniramine, Pyrilamine, Phenylephrine, and Acetaminophen
  • Tablets (U.S.)
• Dexbrompheniramine, Pseudoephedrine, and Acetaminophen
  • Extended-release tablets (U.S.)
• Diphenhydramine, Pseudoephedrine, and Acetaminophen
  • For oral solution (U.S.)
  • Tablets (U.S. and Canada)
• Pheniramine, Phenylephrine, and Acetaminophen
  • For oral solution (Canada)
• Pheniramine, Phenylephrine, Sodium Salicylate, and Caffeine
  • Oral solution (U.S.)
• Pyrilamine, Phenylephrine, Aspirin, and Caffeine
  • Tablets (Canada)
• Triprolidine, Pseudoephedrine, and Acetaminophen
  • Tablets (U.S. and Canada)

Before Using This Medicine

If you are taking this medicinewithout a prescription, carefully read and follow any precautions on the label.For antihistamine, decongestant, and analgesic combinations, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to any of the ingredients contained in this medicine. Ifthis medicine contains aspirin or another salicylate, before taking it, check with your doctor if youhave ever had any unusual or allergic reaction to any of the following medicines:

• Diclofenac (e.g., Voltaren)
• Diflunisal (e.g., Dolobid)
• Etodolac (e.g., Lodine)
• Fenoprofen (e.g., Nalfon)
• Floctafenine
• Flurbiprofen, by mouth (e.g., Ansaid)
• Ibuprofen (e.g., Motrin)
• Indomethacin (e.g., Indocin)
• Ketoprofen (e.g., Orudis)
• 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 othersubstances, such as foods, preservatives, or dyes.

Pregnancy?The occasional use of antihistamine, decongestant,and analgesic combinations is not likely to cause problems in the fetus orin the newborn baby. However, when these medicines are used at higher dosesand/or for a long time, the chance that problems might occur may increase.For the individual ingredients of these combinations, the following apply:

• Acetaminophen?Acetaminophen hasnot been shown to cause birth defects or other problems in humans. However,studies on birth defects have not been done in humans.
• Alcohol?Some of these combinationmedicines contain large amounts of alcohol. Too much use of alcohol duringpregnancy may cause birth defects.
• Antihistamines?Antihistamines havenot been shown to cause problems in humans.
• Caffeine?Studies in humans havenot shown that caffeine causes birth defects. However, studies in animalshave 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 coffeea day).
• Phenylephrine?Studies on birth defectshave not been done in either humans or animals with phenylephrine.
• Pseudoephedrine?Studies on birthdefects with pseudoephedrine have not been done in humans. In animal studiespseudoephedrine did not cause birth defects but did cause a decrease in averageweight, length, and rate of bone formation in the animal fetus when administeredin high doses.
• Salicylates (e.g., aspirin)?Salicylateshave not been shown to cause birth defects in humans. Studies on birth defectsin humans have been done with aspirin. However, salicylates have been shownto cause birth defects in animals.
  Regular use of salicylates late in pregnancy may cause unwanted effectson the heart or blood flow in the fetus or newborn baby. Use of salicylatesduring the last 2 weeks of pregnancy may cause bleeding problems in the fetusbefore or during delivery, or in the newborn baby. Also, too much use of salicylatesduring the last 3 months of pregnancy may increase the length of pregnancy,prolong labor, cause other problems during delivery, or cause severe bleedingin the mother before, during, or after delivery. Do nottake aspirin during the last 3 months of pregnancy unless it has been orderedby your doctor.

Breast-feeding?If you are breast-feeding the chance that problemsmight occur depends on the ingredients of the combination. For the individualingredients of these combinations, the following apply:

• Acetaminophen?Acetaminophen passesinto the breast milk. However, it has not been shown to cause problems innursing babies.
• Alcohol?Alcohol passes into thebreast milk. However, the amount of alcohol in recommended doses of this medicinedoes not usually cause problems in nursing babies.
• Antihistamines?Use is not recommendedsince the chances are greater for this medicine to cause side effects, suchas unusual excitement or irritability, in the nursing baby. Also, since antihistaminestend to decrease the secretions of the body, it is possible that the flowof breast milk may be reduced in some women.
• Caffeine?Small amounts of caffeinepass into the breast milk and may build up in the nursing baby. However, theamount of caffeine in recommended doses of this medicine does not usuallycause problems in nursing babies.
• Decongestants (e.g., phenylephrine, pseudoephedrine)?Decongestants may pass into the breast milk and may cause unwantedeffects in nursing babies of mothers taking this medicine.
• Salicylates (e.g., aspirin, sodium salicylate)?Salicylates pass into the breast milk. Although salicylateshave not been reported to cause problems in nursing babies, it is possiblethat problems may occur if large amounts are taken regularly.

Children?Very young children are usually more sensitive tothe effects of this medicine. Increases in blood pressure, nightmares, unusualexcitement, nervousness, restlessness, or irritability may be more likelyto occur in children. Also, mental changes may be more likely to occur inyoung children taking these combination medicines.

Before giving any of these combination medicines toa child, check the package label very carefully. Some of these medicines aretoo strong for use in children. If you are not certain whether a specificproduct can be given to a child, or if you have any questions about the amountto give, check with your health care professional.

Do not give aspirin or other salicylates to a childwith a fever or other symptoms of a virus infection, especially flu or chickenpox,without first discussing their use with your child's doctor. This isvery important because salicylates may cause a serious illness called Reye'ssyndrome in children with fever caused by a virus infection, especially fluor chickenpox. Also, children may be more sensitive to the aspirin or othersalicylates contained in some of these medicines, especially if they havea fever or have lost large amounts of body fluid because of vomiting, diarrhea,or sweating.

Adolescents?Do not give aspirin or othersalicylates to a teenager with a fever or other symptoms of a virus infection,especially flu or chickenpox, without first discussing their use with yourchild's doctor. This is very important because salicylates may causea serious illness called Reye's syndrome in teenagers with fever caused bya virus infection, especially flu or chickenpox.

Older adults?The elderly are usually more sensitive to the effectsof this medicine. Confusion, difficult or painful urination, dizziness, drowsiness,feeling faint, or dryness of mouth, nose, or throat may be more likely tooccur in elderly patients. Also, nightmares or unusual excitement, nervousness,restlessness, or irritability may be more likely to occur in the elderly.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingantihistamine, decongestant, and analgesic combinations it is especially importantthat your health care professional know if you are taking any other prescription or nonprescription (over-the-counter [OTC])medicine, for example, aspirin or other medicine for allergies. Some medicinesmay change the way this medicine affects your body. Also, the effect of othermedicines may be increased or reduced by some of the ingredients in this medicine.

Other medical problems?The presence of other medicalproblems may affect the use of antihistamine, decongestant, and analgesiccombinations. Make sure you tell your doctor if you have any other medicalproblems, especially:

• Alcohol abuse?Acetaminophen-containing medicines increase thechance of liver damage

• Anemia?Taking a salicylate-containing medicine may make theanemia worse

• Asthma, allergies, and nasal polyps, history of, or
• Asthma attacks?Taking a salicylate-containing medicine maycause an allergic reaction in which breathing becomes difficult; also, althoughantihistamines open tightened bronchial passages, other effects of the antihistaminesmay cause secretions to become thick so that during an asthma attack it mightbe difficult to cough them up

• Diabetes mellitus (sugar diabetes)?The decongestant in thismedicine may put the patient with diabetes at a greater risk of having heartor blood vessel disease

• Enlarged prostate or
• Urinary tract blockage or difficult urination?Some of the effectsof antihistamines may cause urinary problems to get worse

• Glaucoma?A slight increase in inner eye pressure may occur

• Gout?Aspirin- or sodium salicylate-containing medicine maymake the gout worse and reduce the benefit of the medicines used for gout

• Hemophilia or other bleeding problems?Aspirin- or sodium salicylate-containingmedicine increases the chance of bleeding

• Hepatitis or other liver disease?There is a greater chanceof side effects because the medicine is not broken down and may build up inthe body; also, if liver disease is severe there is a greater chance thataspirin-containing medicine may cause bleeding

• Heart or blood vessel disease or
• High blood pressure?The decongestant in this medicine may causethe blood pressure to increase and may also speed up the heart rate; also,caffeine-containing medicine, if taken in large amounts, may have a similareffect on the heart

• Kidney disease (severe)?The kidneys may be affected, especiallyif too much of this medicine is taken for a long time

• Overactive thyroid?If the overactive thyroid has caused a fastheart rate, the decongestant in this medicine may cause the heart rate tospeed up further

• Stomach ulcer or other stomach problems?Salicylate-containingmedicine may make the ulcer worse or cause bleeding of the stomach

Proper Use of This Medicine

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

If this medicine irritates your stomach, you may take it with food or aglass of water or milk, to lessen the irritation.

For patients taking the extended-release tablet form of this medicine:

• Swallow the tablets whole.
• Do not crush, break, or chew before swallowing.

If a combination medicine containing aspirin has astrong vinegar-like odor, do not use it. This odor means the medicineis breaking down. If you have any questions about this, check with your pharmacist.

Dosing?The dose of these combination medicines willbe different for different products. Follow the directionson the box if you are taking this medicine without a prescription. Or, followyour doctor's orders if this medicine was prescribed. The followinginformation includes only the average doses for these combinations.

The number of capsules or tablets or teaspoonfuls of liquid that you takedepends on the strength of the medicine.

There is a large variety of antihistamine, decongestant, and analgesiccombination 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 cold symptoms and sinus pain and congestion:

• For regular (short-acting) oral dosageforms (chewable tablets, capsules, liquid, or tablets):
  • Adults and children 12 years of age and older: Usually the dose is1 to 2 capsules or tablets, or 1 teaspoonful of liquid, every four to sixhours.
  • Children 6 to 12 years of age: Usually the dose is 1 tablet, 4 chewabletablets, or 1 to 2 teaspoonfuls of liquid every four hours.
  • Children up to 6 years of age: Use and dose must be determined byyour doctor.
• For oral dosage forms that must be dissolved (effervescent tablets or powder):
  • Adults and children 12 years of age and older: Usually the dose is2 effervescent tablets or the contents of 1 packet of powder dissolved asdirected on the package.
  • Children up to 12 years of age: Use and dose must be determined byyour doctor.
• For long-acting oral dosage form (tablets):
  • Adults and children 12 years of age and older: Usually the dose is1 to 2 tablets every 12 hours.
  • Children up to 12 years of age: Use and dose must be determined byyour doctor.

Missed dose?If you must take this medicine regularly and youmiss a dose, take it as soon as possible. However, if it is almost time foryour 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 verydangerous 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 causethe medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Beforeyou have any skin tests for allergies, tell the doctor in charge that youare taking this medicine. The results of the test may be affected by the antihistaminein this medicine.

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

The antihistamine in this medicine will add to the effects of alcohol andother central nervous system (CNS) depressants (medicines that slow down thenervous system, possibly causing drowsiness). Some examples of CNS depressantsare other antihistamines or medicine for hay fever, other allergies, or colds;sedatives, tranquilizers, or sleeping medicine; prescription pain medicineor narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics,including some dental anesthetics. Check with your doctorbefore taking any of the above while you are taking this medicine.

Also, stomach problems may be more likely to occur if you drink alcoholicbeverages while taking a medicine that contains aspirin. In addition, drinkinglarge amounts of alcoholic beverages while taking a medicine that containsacetaminophen may cause liver damage.

The antihistamine in this medicine may cause some people to become drowsy,dizzy, or less alert than they are normally. Make sureyou know how you react to this medicine before you drive, use machines, ordo anything else that could be dangerous if you are dizzy or are not alert.

The decongestant in this medicine may cause some people to become nervousor restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of this medicine for each day a fewhours before bedtime. If you have any questions about this, check withyour doctor.

Also, this medicine may add to the CNS stimulant and other effects of diet aids. Do not use medicines for diet or appetitecontrol while taking this medicine unless you have checked with your doctor.

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

Antihistamines may cause dryness of the mouth, nose, and throat. For temporaryrelief of mouth dryness, use sugarless candy or gum, melt bits of ice in yourmouth, or use a saliva substitute. However, if your mouth continues to feeldry for more than 2 weeks, check with your dentist. Continuing dryness ofthe mouth may increase the chance of dental disease, including tooth decay,gum disease, and fungus infections.

Check the label of all over-the-counter (OTC), nonprescription,and prescription medicines you now take. If any contain acetaminophenor aspirin or other salicylates, including diflunisal or bismuth subsalicylate(e.g., Pepto-Bismol), be especially careful. This combination medicine containsacetaminophen and/or a salicylate. Therefore, taking it while taking any othermedicine that contains these drugs may lead to overdose. If you have any questionsabout this, check with your health care professional.

For patients taking aspirin-containing medicine:

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

For diabetic patients taking salicylate-containingmedicine, false urine sugar test results may occur:

• If you take 8 or more 325-mg (5-grain) doses of aspirin every dayfor several days in a row.
• If you take 8 or more 325-mg (5-grain), or 4 or more 500-mg (10-grain),doses of sodium salicylate a day.

Smaller doses or occasional use 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.

Side Effects of This Medicine

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

• too much medicine is taken
• it is taken in large doses
• it is taken for a long time

Get emergency help immediatelyif any of the following symptoms of overdose occur:

For all combinations

Clumsiness or unsteadiness; convulsions(seizures); drowsiness (severe); dryness of mouth, nose, or throat (severe); fastheartbeat; flushing or redness of face; hallucinations (seeing, hearing, or feeling things that are notthere); headache (continuing and/or severe); increased sweating; nausea or vomiting(severe or continuing); shortness of breath or troubledbreathing; stomach cramps or pain (severe or continuing); trouble in sleeping

For acetaminophen-containing only

Diarrhea; loss of appetite; swelling or tenderness in the upper abdomen or stomach area

Note:

Signs of severe acetaminophen overdose may not appear until 2 to 4 daysafter the overdose is taken, but treatment to prevent liver damage or deathmust be started within 24 hours or less after the overdose is taken.

For salicylate-containing only

Any loss of hearing; bloody urine; changes in behavior (in children); confusion; diarrhea (severe or continuing); drowsiness or tiredness (severe, especially in children); fast or deep breathing (especially in children); fever; ringing or buzzing in ears (continuing); uncontrollable flapping movements of the hands(especially in elderly patients); unusual thirst; vision problems

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

More common

Nausea or vomiting; stomach pain (mild)

Less common or rare

Bloody or black tarry stools; changesin urine or problems with urination; skin rash, hives,or itching; sore throat and fever; swelling of face, feet, or lower legs; tightnessin chest; unusual bleeding or bruising; unusual tiredness or weakness; vomitingof blood or material that looks like coffee grounds; weight gain (unusual); yellow eyes or skin

Other sideeffects may occur that usually do not need medical attention. These side effectsmay 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 arebothersome:

More common

Drowsiness; heartburn or indigestion(for salicylate-containing medicines); thickeningof mucus

Less common?more common with high doses

Blurred vision; confusion; difficult or painful urination; dizziness; dryness of mouth, nose, or throat; headache; loss of appetite; nightmares; pounding heartbeat; ringing or buzzing in ears; skin rash; stomach upset or stomach pain; unusual excitement, nervousness, restlessness, or irritability

Not all of the side effects listedabove have been reported for each of these medicines, but they have been reportedfor at least one of them. There are some similarities among these combinationmedicines, 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. Ifyou notice any other effects, check with your doctor.