SSKI Oral

In the U.S.

• Ala-Hist AC
• Ala-Hist DHC
• Alavert-D 12-Hour
• Aldex D
• Alka-Seltzer Plus Cold and Sinus
• AllanVan-S
• Allegra-D
• Aller-Chlor
• Allerx-D
• Allfen CD
• Allres PD
• Amibid LA
• Benadryl
• BPM Pseudo
• Bromcomp HC
• Bromfed-PD
• BroveX CB
• By-Ache
• Canges-HC
• Ceron
• Ceron-DM
• Chlor-Trimeton Nasal Decongestant
• Clarinex-D
• Codimal DH
• Cotab A
• Cotabflu
• Cypex-LA
• Deconamine SR
• Delsym
• Dexphen w/C
• Donatussin DC
• Donnatussin
• D-Tann HC
• EndaCof-DC
• FluTuss XP
• Genapap Sinus
• G Phen DM
• HC Tussive
• Histex PD
• Humibid DM
• Hycodan
• Hycofenix
• Hydone
• HyTan
• Kie
• Levall 12
• Lusonal
• Maxiflu CD
• Maxiphen CD
• M-End Max D
• Mucinex D
• Nasop
• Notuss-Forte
• Notuss-NX
• Notuss-NXD
• Novahistine DH
• Pancof HC
• Pediatex 12
• Pediatex 12D
• Pediatex 12DM
• Pediatex-D
• Phenergan w/Codeine
• Phenflu CD
• Phenylephrine CM
• Phenylhistine
• Poly-Tussin AC
• Poly-Tussin DHC
• Pro-Clear AC
• Promethazine VC With Codeine
• Pro-Red AC
• RelaTuss HC
• Robitussin
• Robitussin DM
• Ryneze
• Semprex-D
• SSKI
• Stahist
• Sudafed
• SymTan
• SymTan A
• Tanafed DMX
• Tannate Pediatric
• Tessalon Perles
• Tricold Pediatric Drops
• Tripohist D
• Tussi-12 S
• TussiCaps
• Tuzistra XR
• Tylenol
• Uni-Tann D
• Vituz
• Xpect-PE
• Y-Cof DM
• Z-COF DM
• Zhist
• Zodryl DAC 25
• Zotex-D
• Zymine
• Zymine HC
• ZyrTEC-D

In Canada

• Actifed A
• Actifed Plus
• Actifed Plus Extra Strength
• Actifed Plus Head Cold And Sinus Extra Strength
• Actifed Sinus Regular
• Adult Nighttime Cold/Flu Relief - Cherry Flavor
• Adult Nighttime Cold/Flu Relief - Original Flavor
• Allergy Sinus Medication Extra Strength
• Atoma Night Adult Cold/Flu Relief
• Balminil
• Balminil Dm Children
• Balminil Dm Sugar-Free

Available Dosage Forms:

• Suspension
• Tablet, Disintegrating
• Tablet, Chewable
• Solution
• Tablet
• Syrup
• Suspension, Extended Release
• Tablet, Extended Release
• Elixir
• Liquid
• Capsule, Extended Release
• Capsule
• Capsule, Liquid Filled
• Capsule, Extended Release, 12 HR
• Packet
• Tablet, Extended Release, 12 HR
• Film
• Tablet, Effervescent
• Powder for Suspension
• Powder for Solution
• Kit
• Tablet, Extended Release, 24 HR
• Capsule, Extended Release, 24 HR
• Tablet, Enteric Coated

Cough/cold combinations are used mainly to relieve the cough due to colds, influenza, or hay fever. They are not to be used for the chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (pronounced flem) with the cough.

Cough/cold combination products contain more than one ingredient. For example, some products may contain an antihistamine, a decongestant, and an analgesic, in addition to a medicine for coughing. If you are treating yourself, it is important to select a product that is best for your symptoms. Also, in general, it is best to buy a product that includes only those medicines you really need. If you have questions about which product to buy, check with your pharmacist.

Since different products contain ingredients that will have different precautions and side effects, it is important that you know the ingredients of the medicine you are taking. The different kinds of ingredients that may be found in cough/cold combinations include:

Antihistamines—Antihistamines are used to relieve or prevent the symptoms of hay fever and other types of allergy. They also help relieve some symptoms of the common cold, such as sneezing and runny nose. They work by preventing the effects of a substance called histamine, which is produced by the body. Some examples of antihistamines contained in these combinations are:

• Bromodiphenhydramine
• Brompheniramine
• Carbinoxamine
• Chlorpheniramine
• Dexchlorpheniramine
• Diphenhydramine
• Doxylamine
• Phenindamine
• Pheniramine
• Phenyltoloxamine
• Pyrilamine
• Promethazine
• Triprolidine

Decongestants—Decongestants produce a narrowing of blood vessels. This leads to clearing of nasal congestion. However, this effect may also increase blood pressure in patients who have high blood pressure. These include:

• Ephedrine
• Phenylephrine
• Pseudoephedrine

Antitussives—Antitussives help relieve coughing and are some contain a narcotic. These antitussives act directly on the cough center in the brain. Narcotics may become habit-forming, causing mental or physical dependence, if used for a long time. Physical dependence may lead to withdrawal side effects when you stop taking the medicine.

Narcotic antitussives
• Codeine
• Dihydrocodeine
• Hydrocodone
• Hydromorphone

Non-narcotic antitussives
• Carbetapentane
• Caramiphen
• Dextromethorphan

Expectorants—Expectorants work by loosening the mucus or phlegm in the lungs. The main expectorant used in cough and cold medicines is guaifenesin. Other ingredients added as expectorants (for example, ammonium chloride, calcium iodide, iodinated glycerol, ipecac, potassium guaiacolsulfonate, potassium iodide, and sodium citrate) have not been proven to be effective. In general, the best thing you can do to loosen mucus or phlegm is to drink plenty of water.

Analgesics—Analgesics are used in these combination medicines to help relieve the aches and pain that may occur with the common cold. These include:

• Acetaminophen
• Aspirin
• Other salicylates such as salicylamide and sodium salicylate

The use of too much acetaminophen and salicylates at the same time may cause kidney damage or cancer of the kidney or urinary bladder. This may occur 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.

Anticholinergics—Anticholinergics, such as homatropine may help produce a drying effect in the nose and chest.

These cough and cold combinations are available both over-the-counter (OTC) and with your doctor's prescription.

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 .

This section provides information on the proper use of a number of products that contain cough and cold combinations. It may not be specific to SSKI. Please read with care.

To help loosen mucus or phlegm in the lungs, drink a glass of water after each dose of this medicine, unless otherwise directed by your doctor.

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.

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 .

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

• Swallow the capsule or tablet 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.

For patients taking the extended-release oral solution or oral suspension form of this medicine:

• Do not dilute with fluids or mix with other drugs.

For patients taking a combination medicine containing an antihistamine and/or aspirin or other salicylate:

• Take with food or a glass of water or milk to lessen stomach irritation, if necessary.

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.

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.

Keep the liquid form of this medicine from freezing. Do not refrigerate the syrup.

If your cough has not improved after 7 days or if you have a high fever, skin rash, continuing headache, or sore throat with the cough, check with your doctor. These signs may mean that you have other medical problems.

For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine):

• Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual

For nursing mothers taking a codeine-containing medicine or any other narcotic cough medicine (dihydrocodeine, hydrocodone, or hydromorphone):

• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every two to three hours and should not sleep more than four hours at a time.
• Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention .

For patients taking antihistamine-containing 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.
• 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 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.
• This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally.
• 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.
• When taking antihistamines on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin at the same time (as in arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by the antihistamine.
• Antihistamines may cause dryness of the mouth. 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 medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

For patients taking decongestant-containing medicine:

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

For patients taking narcotic antitussive (codeine, dihydrocodeine, hydrocodone, or hydromorphone)-containing medicine:

• This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are 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.
• This medicine may cause some people to become drowsy, dizzy, less alert than they are normally, or to feel a false sense of well-being. 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 clearheaded.
• Nausea or vomiting may occur after taking a narcotic antitussive. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your doctor.
• Dizziness, lightheadedness, or fainting may be especially likely to occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.
• 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.

For patients taking iodide (calcium iodide, iodinated glycerol, or potassium iodide)-containing medicine:

• Make sure your doctor knows if you are planning to have any future thyroid tests. The results of the thyroid test may be affected by the iodine in this medicine.

For patients taking analgesic-containing medicine:

• Check the label of all nonprescription (over-the-counter [OTC]), and prescription medicines you now take. If any contain acetaminophen or aspirin or other salicylates, including diflunisal or bismuth subsalicylate, be especially careful. Taking them while taking a cough/cold combination medicine that already contains them may lead to overdose. If you have any questions about this, check with your health care professional.
• 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 aspirin- or sodium salicylate-containing medicine:

• False urine sugar test results may occur:
  • If you take 8 or more 325-mg doses of aspirin every day for several days in a row.
  • If you take 8 or more 325-mg or 4 or more 500-mg doses of sodium salicylate.
• Smaller doses or occasional use of aspirin or sodium salicylate 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 homatropine-containing medicine:

• This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking 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:

If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:

• Cold, clammy skin
• confusion (severe)
• convulsions (seizures)
• drowsiness or dizziness (severe)
• nervousness or restlessness (severe)
• pinpoint pupils of eyes
• slow heartbeat
• slow or troubled breathing
• Difficulty breathing
• difficulty nursing
• increased sleepiness (more than usual)
• limpness

• Diarrhea
• increased sweating
• loss of appetite
• nausea or vomiting
• stomach cramps or pain
• swelling or tenderness in the upper abdomen or stomach area

• Any loss of hearing
• bloody urine
• confusion
• convulsions (seizures)
• dizziness or lightheadedness
• drowsiness (severe)
• excitement or nervousness (severe)
• fast or deep breathing
• fever
• hallucinations (seeing, hearing, or feeling things that are not there)
• increased sweating
• nausea or vomiting (severe or continuing)
• shortness of breath or troubled breathing (for salicylamide only)
• stomach pain (severe or continuing)
• uncontrollable flapping movements of the hands, especially in elderly patients
• unusual thirst
• vision problems

• Fast, pounding, or irregular heartbeat
• headache (continuing and severe)
• nausea or vomiting (severe)
• nervousness or restlessness (severe)
• shortness of breath or troubled breathing (severe or continuing)

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

• Skin rash, hives, and/or itching

• Clumsiness or unsteadiness
• convulsions (seizures
• drowsiness (severe)
• dryness of mouth, nose, or throat (severe)
• flushing or redness of face
• hallucinations (seeing, hearing, or feeling things that are not there)
• restlessness (severe)
• shortness of breath or troubled breathing
• slow or fast heartbeat

• Headache (continuing)
• increased watering of mouth
• loss of appetite
• metallic taste
• skin rash, hives, or redness
• sore throat
• swelling of face, lips, or eyelids

• Unexplained sore throat and fever
• unusual tiredness or weakness
• 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:

• Constipation
• decreased sweating
• difficult or painful urination
• dizziness or lightheadedness
• drowsiness
• dryness of mouth, nose, or throat
• false sense of well-being
• increased sensitivity of skin to sun
• nausea or vomiting
• nightmares
• stomach pain
• thickening of mucus
• trouble in sleeping
• unusual excitement, nervousness, restlessness, or irritability
• unusual tiredness or weakness

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.

Nausea, vomiting, stomach ache, diarrhea, metallic taste in the mouth, fever, headache, or acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: burning mouth/throat, sore teeth/gums, swelling inside the mouth, increased saliva, eye irritation/swollen eyelids, severe headache, swelling of the front of the neck/throat (goiter), signs of decreased thyroid gland function (e.g., weight gain, cold intolerance, slow/irregular heartbeat, constipation, unusual tiredness), confusion, numbness/tingling/pain/weakness of the hands/feet.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, black stools, vomit that looks like coffee grounds, bloody diarrhea.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fever with joint pain.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.