6172. Various drugs. (F.D.C. No. 44202. S. Nos. 72-946/53 P.) QUANTITY : 2,000 individually cartoned tubes, 10 tablets each, of Asfri-Quwane, 8,500 individually cartoned tubes, 30 tablets each, of Citrovit, 800 individually cartoned btls., 40 tablets each, of CeferMos Metallic Therapy, 2,000 individ- ually cartoned btls. of Bitter Tonic Giuliani, 3,000 individually cartoned btls., 20 tablets each, of Giuliani Bitter Laxative, 250 individually cartoned 150-cc. btls. of Gastro-Zyme, 80 individually cartoned boxes of Coffosil, 80 boxes, 40 tablets each, of Zimotris Composition, at New York, N.Y., in possession of Italian Drugs Importing Co. SHIPPED : The Gastro-Zyme was imported sometime prior to January 1957, and the other articles between 6-21-57 and 7-23-59, from Italy. LABEL IN PAET: (Ctn. & tube) "Aspi-Quinine Each Tab. Con.; Aspirin 0.40 Gm.-Quin. Hydrobromide 0.05 Gm. Indications * * * Warning"; "Citrovit * * * Citro-Alkaline Tablets with Vitamin C Gastric Antacid Dosage:"; (ctn. & btl.) "Ceferbios Metallic Therapy With Vit. BM and Folic Acid * * * Each Tablet Contains: Iron Salt of Inositol Hexaphosphoric Acid 0.20 Gm. Cop- per Salt of Inositol Hexaphosphoric Acid 0.004 Gm. Manganese Salt of Inositol Hexaphosphoric Acid 0.0065 Gm. Cobalt Salt of Inositol Hexaphosphoric Acid 0.00075 Gm. Folic Acid 0.0005 Gm. Vitamin Bu 2 Mcgm. Aromatized Sugar q.s. * * * Control No. 26159 Lot No. 513" ; "Bitter Tonic Giuliani Each 1 ce. contains: Aromatic Ext. Calamus 25 mg. Tine. Gentian 40 mg. Acqueous Tine. Boldus 5 mg.-Sodium Acid Carbonate 5 mg.-Glyeerine 50 mg.-Distilled Water 250 mg.-Aromatic Excipients 95? Alcohol 100 mg., Sugar 170 mg., Water 33 mg., 2 drops Mint Essence, 2 drops Anise Essence, 2 drops Cinnamon Essence, 625 mg. Alcohol 14? by volume"; "Giuliani Bitter Laxative * * * Each Tablet contains: Extract Rhubarb 20 Mg.-Extract Cascara Sagrada 20 Mg.-Phenolphthalein 60 Mg.-Excipients and Sugar Q. S."; "Gastro-Zyme I.S.M. Oral Each 100 cc. contains: Extract of fresh gastric mucous of swine 15 Gms. Extract of fresh gastric muscle of swine 10 gms. Peptones from alimentary proteins 7 Gms. Combined in a pleasantly flavored vehicle con- sisting of glycerin, water and flavor. * * * Control No. 378"; "Coffosil * * * Eacb 100 grams contains: Thymus Nepeta Extract 2 gm. Potassium Sulf o- guaiacolate 2-5 gm. Sodium Glycerophosphate 1 gm. Sodium Formate 3 gm. Glyceric Syrup Solution Q.S. 100 gm. Indications * * * Suggested Dosage * * * Warning * * * Control No. 593105"; and (box) Zimotris Com- position: Each tablet contains: Pepsin 1:2500-50 mg. (Equivalent to 300 Units) Trypsin 1: 150-25 mg. (Equivalent to 350 Units) Lipase (F.U.) 25 mg.; Amylase 1: 50-50 mg. Indications * * * Dosage." ACCOMPANYING LABELING: Leaflets entitled "Pharmaceutical Products of Ex- ceptional Merit" and "Specialita' Medicinali Di Porvata Efflcacia Curativa," "Giuliani Bitter Laxative Tablets," and "Gastro-Zyme I.S.M." RESULTS OF INVESTIGATION : The leaflets entitled "Pharmaceutical Products of Exceptional Merit" and "Specialita' Medicina Di Porvata Efflcacia Curativa" were printed locally for the dealer and used to promote sales of the articles. LIBELED : 2-1-60, S. Dist. N.Y. CHARGE: 502(a)-while held for sale, the labeling which accompanied the articles, namely, the leaflets entitled "Specialita' Medicinali Di Porvata Efflcacia Curativa" and "Pharmaceutical Products" contained false and mis- leading representations that the Aspi-Quinine was an adequate and effective treatment for colds, influenza, neuralgia, and rheumatism; that the Citrovit was an adequate and effective treatment for conditions of the liver and intestines, would help to eliminate excess uric acid, correct digestive secretions and was an infallible remedy; that the Cefebrios Metallic Therapy was an adequate and effective treatment for the nervous system, for the tired feeling, and for all kinds of anemia; and would make one feel stronger in just a few days; that the Bitter Tonic Giuliani was an adequate and effective treatment for dizzi- ness, headache, heartburn, constipation, loss of appetite, hyperacidity, nausea* eructations and other intestinal disturbances; that the Giuliani Bitter Laxa- tive was an adequate and effective treatment for habitual constipation; that the Coffosil was an adequate and effective treatment for bronchial conditions, bronchial catarrh, sore throat, and laryngitis; and that the Zimotris Composi- tion was an adequate and effective treatment for constipation, intestinal fer- mentation, digestive disturbances, and would eliminate gas, boils, skin erup- tions, and arteriosclerosis; 502(b)-the Citrovit failed to bear a label contain- 573794-60?2 ing (1) the name and place of business of the manufacturer, packer, or dis- tributor and (2) an accurate statement of the quantity of contents; 502(e) (2)-the Citrovit was fabricated from two or more ingredients, and its label failed to bear the common or usual name of each active ingredient; and 502(f)-The labeling of the Aspi-Quinine and the Giuliani Bitter Laxative failed to bear (1) adequate directions for use and (2) (Aspi-Quinine) adequate warnings for the protection of the user and (Giuliani Bitter Laxative) a warn- ing statement for phenolphthalein; 502(a)-when shipped and while held for sale, the labeling of the Gastro-Zyme, namely, the leaflet entitled "Gastro- Zyme I.S.M.," contained false and misleading representations that the article was an adequate and effective treatment for chronic (atrophic) gastritis; gastric achylia; dyspepsia in anemic convalescent and aged subjects, infants and over-worked people; gastric neuroses; senile gastric hypotonia and hypo- chylia; and acute and chronic gastric catarrh. DISPOSITION: 3-1-60. Consent-claimed by Italian Drugs Importing Co., Inc., New York, N.Y., and relabeled.