[Posted 10/09/2008] FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state “do not use” in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns. For more information visit the FDA website at: [Web] and [Web].
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Shake well before using. Use a specially marked spoon or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take your medicine at regular intervals. Do not take it more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years old for selected conditions, precautions do apply. Do not use this medicine in children less than 2 years old.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
alcohol
barbiturate medicines for sleep or treating seizure disorder
MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
What should I watch for while using this medicine?
Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.
This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
agitation, nervousness, excitability, not able to sleep
blurred vision
confusion
fainting spells
fast, irregular heartbeat
fever
seizures
slurred speech
trouble passing urine or change in the amount of urine
tremor
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
Store at room temperature, between 15 and 30 degrees C (59 and 86 degrees F). Keep medicine bottle tightly closed. Protect from light. Throw away any unused medicine after the expiration date.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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