$8.00

ADVIL COLD AND SINUS

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.

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.

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.

• 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