Brand Names:

• Alavert-D 12-Hour
• Aldex D
• AllanVan-S
• Allegra-D
• BPM Pseudo
• Bromfed-PD
• Ceron
• Deconamine SR
• Naphcon A
• Pediatex 12D
• Pediatex-D
• Semprex-D
• Tannate Pediatric
• Tripohist D
• Uni-Tann D
• Zyrtec-D
• Allergy Formula Liquid
• Benadryl Allergy Children's
• Benadryl Children's
• Benylin-E
• Benylin E Extra Strength Chest Congestion
• Benylin For Allergies
• Benylin For Infants Oral Drops - Decongestant
• Broncho-Grippex Expectorant
• Buckley's Jack & Jill Bedtime
• Clear Allergy Formula For Adults And Children
• Cold Relief
• Corsym

Dosage Forms:

• Solution
• Capsule, Extended Release
• Suspension
• Tablet, Extended Release
• Tablet, Extended Release, 12 HR
• Capsule
• Tablet, Extended Release, 24 HR
• Tablet, Chewable
• Syrup
• Tablet
• Suspension, Extended Release
• Liquid
• Capsule, Extended Release, 24 HR
• Elixir
• Kit
• Tablet, Disintegrating

Uses of This Medicine:

In November 2000, the Food and Drug Administration (FDA) issued a public health warning regarding phenylpropanolamine (PPA) due to the risk of hemorrhagic stroke. The FDA, supported by results of a research program, requested that manufacturers voluntarily discontinue marketing products that contain PPA and that consumers work with their healthcare providers to select alternative products.

Antihistamine and decongestant combinations are used to treat the nasal congestion (stuffy nose), sneezing, and runny nose caused by colds and hay fever.

Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Antihistamines contained in these combinations are:

• acrivastine, azatadine, brompheniramine, carbinoxamine, chlorpheniramine, clemastine, dexbrompheniramine, diphenhydramine, loratadine, pheniramine, phenyltoloxamine, promethazine, pyrilamine, and triprolidine.

The 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.

Some of these combinations are available only with your doctor's prescription. Others are available without a prescription; however, your doctor may have special instructions on the proper dose of the medicine for your medical condition.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 2 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using This Medicine:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Very young children are usually more sensitive to the effects of this medicine. Increases in blood pressure, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in children. 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.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 2 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Older adults—

Confusion, difficult and painful urination, dizziness, drowsiness, dryness of mouth, or convulsions (seizures) may be more likely to occur in the elderly, who are usually more sensitive to the effects of this medicine. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients.

Pregnancy—

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

• Alcohol—Some of these combination medicines contain alcohol. Too much use of alcohol during pregnancy may cause birth defects.
• Phenylephrine—Studies on birth defects have not been done in either humans or animals with phenylephrine.
• Promethazine—Phenothiazines, such as promethazine (contained in some of these combination medicines [e.g., Phenergan-D]), have been shown to cause jaundice and muscle tremors in a few newborn infants whose mothers received phenothiazines during pregnancy. Also, the newborn baby may have blood clotting problems if promethazine is taken by the mother within 2 weeks before delivery.
• Pseudoephedrine—Studies on birth defects with pseudoephedrine have not been done in humans. In animal studies pseudoephedrine did not cause birth defects but did cause a decrease in average weight, length, and rate of bone formation in the animal fetus when administered in high doses.

Breast-feeding—

Small amounts of antihistamines and decongestants pass into the breast milk. Use is not recommended since the chances are greater for this medicine to cause side effects, such as unusual excitement or irritability, in the nursing baby. Also, since antihistamines tend to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some patients. It is not known yet whether loratadine causes these same side effects.

Other medicines—

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Acecainide
• Ajmaline
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Amprenavir
• Aprepitant
• Aprindine
• Arsenic Trioxide
• Astemizole
• Azimilide
• Bepridil
• Bretylium
• Chloroquine
• Cisapride
• Clarithromycin
• Clorgyline
• Darunavir
• Delavirdine
• Desipramine
• Dibenzepin
• Dihydroergotamine
• Disopyramide
• Dofetilide
• Doxepin
• Enflurane
• Erythromycin
• Flecainide
• Fluconazole
• Fluoxetine
• Fluvoxamine
• Fosaprepitant
• Foscarnet
• Furazolidone
• Gemifloxacin
• Grepafloxacin
• Haloperidol
• Halothane
• Hydroquinidine
• Ibutilide
• Imipramine
• Indinavir
• Iproniazid
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ketoconazole
• Levomethadyl
• Lidoflazine
• Lopinavir
• Lorcainide
• Mefloquine
• Mesoridazine
• Mibefradil
• Moclobemide
• Nefazodone
• Nialamide
• Nortriptyline
• Octreotide
• Pargyline
• Pentamidine
• Phenelzine
• Pimozide
• Pirmenol
• Posaconazole
• Potassium Chloride
• Prajmaline
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Propafenone
• Quetiapine
• Quinidine
• Rasagiline
• Risperidone
• Ritonavir
• Saquinavir
• Selegiline
• Sematilide
• Sertindole
• Sibutramine
• Sotalol
• Sparfloxacin
• Spiramycin
• Sulfamethoxazole
• Sultopride
• Tedisamil
• Telithromycin
• Thioridazine
• Tipranavir
• Toloxatone
• Tranylcypromine
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Troleandomycin
• Vasopressin
• Voriconazole
• Ziprasidone
• Zolmitriptan
• Zotepine

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Amitriptyline
• Amoxapine
• Bromocriptine
• Chloral Hydrate
• Clomipramine
• Dalfopristin
• Desipramine
• Dolasetron
• Dothiepin
• Doxepin
• Droperidol
• Fluoxetine
• Furazolidone
• Guanethidine
• Halofantrine
• Imipramine
• Isradipine
• Lanreotide
• Linezolid
• Lofepramine
• Methyldopa
• Midodrine
• Nelfinavir
• Nortriptyline
• Opipramol
• Paroxetine
• Protriptyline
• Quinupristin
• Sertraline
• Sibutramine
• Trimipramine
• Zileuton

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitus—The decongestant in this medicine may put diabetic patients at a greater risk of having heart or blood vessel disease

• Enlarged prostate or
• Urinary tract blockage or difficult urination—Some of the effects of antihistamines may make urinary problems worse.

• Glaucoma—A slight increase in inner eye pressure may occur.

• 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

• Kidney disease—Higher blood levels of loratadine may result, which may increase the chance of side effects. The dosage of loratadine-containing combination may need to be reduced

• Liver disease—Higher blood levels of loratadine may result, which may increase the chance of side effects

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

• Urinary retention—Condition may be worsened with use of pseudoephedrine

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.

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

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

• Swallow it whole.
• Do not crush, break, or chew before swallowing.
• If the capsule is too large to swallow, you may mix the contents of the capsule with applesauce, jelly, honey, or syrup and swallow without chewing.

Dosing—

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

There is a large variety of antihistamine and decongestant 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.

Follow your doctor's orders if this medicine was prescribed. Or, follow the directions on the box if you are buying this medicine without a prescription

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 2 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Missed dose—

If you miss a dose of this medicine, 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—

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

Before you have any skin tests for allergies, tell the doctor in charge that you are taking this medicine. The results of the test may be affected by the antihistamine in this medicine.

When taking antihistamines (contained in this combination medicine) on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin at the same time (as for arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by the antihistamine.

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

The antihistamine in this medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Some antihistamines are more likely to cause drowsiness than others (loratadine , for example, rarely produces this effect). Make sure you know how you react before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

The decongestant in this medicine may add to the central nervous system (CNS) stimulant and other effects of diet aids. Do not use medicines for diet or appetite control while taking this medicine unless you have checked with your doctor

The decongestant in this medicine may cause some people to be 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.

Antihistamines may cause dryness of the mouth, nose, and throat. Some antihistamines are more likely to cause dryness of the mouth than others (loratadine , for example, rarely produces this effect). For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

For patients using promethazine-containing medicine:

• This medicine controls nausea and vomiting. For this reason, it may cover up the signs of overdose caused by other medicines or the symptoms of intestinal blockage. This will make it difficult for your doctor to diagnose these conditions. Make sure your doctor knows that you are taking this medicine if you have other symptoms such as stomach or lower abdominal pain, cramping, or soreness. Also, if you think you may have taken an overdose of any medicine, tell your doctor that you are taking this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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, or it is taken for a long period of time.

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

Clumsiness or unsteadiness

convulsions (seizures)

drowsiness (severe)

dryness of mouth, nose, or throat (severe)

hallucinations (seeing, hearing, or feeling things that are not there

headache (continuing)

shortness of breath or troubled breathing

slow, fast, or irregular heartbeat

trouble in sleeping

For promethazine only

Muscle spasms (especially of neck and back)

restlessness

shuffling walk

tic-like (jerky) movements of head and face

trembling and shaking of hands

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Back, leg or stomach pain

black, sticky stools

bleeding gums

blood, cloudy or dark urine, or sudden decrease in amount of urine

blood pressure increased

blurred vision

chest pain

confusion

diarrhea

dizziness

faintness, or lightheadedness when getting up from a lying or sitting position

fever or chills

light-colored stools

mood or mental changes

nosebleeds

sore throat and fever

skin rash or hives

stillbirth

swollen mouth, throat, face, fingers, feet, glands or lower legs

sweating suddenly

tightness in chest

troubled breathing

twitching, twisting, or uncontrolled repetitive movements of face

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood

weight gain suddenly

yellow or pale eyes or skin

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

(rare with loratadine-containing combination)

Drowsiness

thickening of the bronchial secretions

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 pain (more common with pyrilamine)

unusual excitement, nervousness, restlessness, or irritability

unusual sleepiness, weakness or drowsiness, extreme tiredness

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