Geplaatst op 14 mei 2008 - 20:20
Geplaatst op 15 mei 2008 - 00:20
In reviewing all cough, cold, allergy, bronchodilator, and antiasthmatic non-prescription drug products the Panel studied some 90 active ingredients. These ingredients were divided into six groups (plus a miscellaneous classification):
.Antitussives, which are cough suppressants.
.Expectorants, which help bring up mucus in the bronchial airways so it can be spit out.
.Bronchodilators, which enlarge the bronchial passages to make it easier for people with asthma to breathe.
.Anticholingerics, which dry up watery secretions in the nose and eyes.
.Nasal decongestants, which open up the nasal passages.
.Antihistamines, a class of drugs used to relieve sneezing and watery and itchy eyes, usually associated with hay fever an other allergies.
Each ingredient reviewed was placed in one of three categories:
Category I - Generally recognized as safe and effective and not mislabeled.
Category II - Not generally recognized as safe and effective or mislabeled. Such ingredients and labeling claims will be removed from products within six months after FDA issues its final regulations on cough, cold, and related nonprescription drug products.
Category III - Available data insufficient to permit final classification at this time. The Panel recommended that when FDA issues its final regulations ingredients which are placed in this category be permitted to remain on the market for a stipulated length of time if the manufacturer immediately begins tests to satisfy the questions raised by the Panel.
The Panel found that there are insufficient data to classify the following ingredients. It recommended that these ingredients be permitted to remain on the market from three to five years if their manufacturers immediately begin tests to answer the questions raised by the Panel.
Antitussives Beechwood creosote Camphor (topical/inhalant) Caramiphen edisylate Carbetapentane citrate Cod liver oil Elm bark Ethylmorphine hydrochloride Eucalyptol/eucalyptus oil (topical/inhalant) Horehound (horehound fluidextract) Menthol/peppermint oil (topical/inhalant) Noscapine (noscapine hydrochloride) Oil of turpentine (topical/inhalant) Thymol
Nasal Decongestants Beechwood creosote Bornyl acetate (topical) Camphor (topical/inhalant) Cedar leaf oil (topical) 1-Desoxyephedrine (inhalant) Ephedrine (oral) Ephedrine hydrochloride (oral) Ephedrine sulfate (oral) Eucalyptol/eucalyptus oil (topical/inhalant) Menthol/peppermint oil (topical/inhalant) Oil of turpentine (topical/inhalant) Phenylpropanolamine hydrochloride (topical) Racephedrine hydrochloride (oral) Thenyldiamine hydrochloride (topical) Thymol (inhalant)
Anticholinergics Atropine sulfate (oral) Atropine (d, dl hyoscyamine) (oral) Scopolamine (1-hyoscine) (oral)
Expectorants Ammonium chloride Beechwood creosote Camphor (topical/inhalant) Compound tincture of benzoin (inhalant) Compound white pine syrup Eucalptol/eucalyptus oil (topical/inhalant) Extract white pine compound Glyceryl guaiacolate Ipecac syrup Menthol/peppermint oil (topical/inhalant) Oil of turpentine (topical/inhalant) Pine tar Potassium guaiacol sulfonate Sodium citrate Syrup of pine tar Terpin hydrate Terpin hydrate elixir Tincture of benzoin (inhalant) Tolu Tolu balsam Tolu balsam tincture White pine
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