Health Guide
Drug Guide

Decongestant and analgesic combinations (Oral route)

Brand Names:

Dosage Forms:

Uses of This Medicine:

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.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 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. 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:

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Older adults

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

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:

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:

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. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 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.

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.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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.

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:

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:

For ibuprofen-containing medicines:

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.

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.. 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.

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:

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:

For diabetic patients taking salicylate-containing medicine:

For patients taking ibuprofen-containing 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.

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, if it is taken in large doses, or if it is taken for a long period of time.

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

For all combinations
Convulsions (seizures)
dizziness or light-headedness (severe)
fast, slow, or irregular heartbeat
hallucinations (seeing, hearing, or feeling things that are not there)
headache (continuing and severe)
increased sweating
mood or mental changes
nausea or vomiting (severe or continuing)
nervousness or restlessness (severe)
shortness of breath or troubled breathing
stomach cramps or pain (severe or continuing)
swelling or tenderness in the upper abdomen or stomach area
trouble in sleeping
For acetaminophen-containing only
Diarrhea
loss of appetite
For aspirin- or salicylamide-containing only
Any loss of hearing
changes in behavior (in children)
confusion
diarrhea (severe or continuing)
drowsiness or tiredness (severe, especially in children)
fast or deep breathing (especially in children)
ringing or buzzing in ears (continuing)
uncontrollable flapping movements of the hands, (especially in elderly patients)
unexplained fever
unusual thirst
vision problems

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

More common
Nausea, vomiting, or stomach pain (mild for combinations containing aspirin or ibuprofen)
Less common or rare
Bloody or black, tarry stools
bloody or cloudy urine
blurred vision or any changes in vision or eyes
changes in facial skin color
changes in hearing
changes or problems with urination
difficult or painful urination
fever
headache, severe, with fever and stiff neck
increased blood pressure
muscle cramps or pain
skin rash, hives, or itching
sores, ulcers, or white spots on lips or in mouth
swelling of face, fingers, feet, or lower legs
swollen and/or painful glands
unexplained sore throat and fever
unusual bleeding or bruising
unusual tiredness or weakness
vomiting of blood or material that looks like coffee grounds
weight gain (unusual)
yellow 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
Heartburn or indigestion (for medicines containing salicylate or ibuprofen)
nervousness or restlessness
Less common
Drowsiness (for medicines containing salicylamide)

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 10/12/2016

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