LABELLING PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 1. NAME OF THE MEDICINAL PRODUCT {(Invented) name <strength> pharmaceutical form} 2. STATEMENT OF ACTIVE SUBSTANCE(S) 100 ml of oral liquid contain 71.5 ml extract (as liquid extract) (equivalent to 2.01 g mixture of herbal substances) from Artemisia absinthium L., herba (wormwood herb), Gentiana lutea L., radix (gentian root), Angelica archangelica L., radix (angelica root), Commiphora molmol Engler, gummi-resina (myrrh), Taraxacum officinale Weber ex Wigg., radix (dandelion root), Curcuma zedoaria (Christm.) Roscoe, rhizoma (zedoary rhizome), Juglans regia L., folium (walnut leaves), Acorus calamus L., rhizoma (calamus rhizome), Potentilla erecta (L.) Raeusch., rhizoma (tormentil), Marubium vulgare L., herba (white horehound), Valeriana officinalis L., radix (valerian root), Cinnamomum verum J.S. Presl, cortex (cinnamon), Elettaria cardamomum (L.) Maton, fructus (cardamom fruit). (66/180/328/367/260/294/260/38/50/32/54/54/27 mg) Extraction solvent: ethanol 96.3 % V/V / water (1:1) DER 1:33 - 37 3. LIST OF EXCIPIENTS Contains 38 vol % ethanol (alcohol), i.e. up to 1.5 g per dose (5 ml), equivalent to 37.5 ml beer, 15 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy. 4. PHARMACEUTICAL FORM AND CONTENTS Oral solution 50 ml 100 ml 250 ml 500 ml 1000 ml 5. METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. Oral use. With measuring cup for dosing. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 1 7. OTHER SPECIAL WARNING(S), IF NECESSARY [for HR only] {(Invented) Name} should not be used in children and adolescents under 18 years. 8. EXPIRY DATE EXP Shelf life after first opening: 1 year. 9. SPECIAL STORAGE CONDITIONS Do not store above 25C after first opening. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Registration holder: RIVIERA Pharma & Cosmetics GmbH Holzhackerstraße 1 3430 Tulln Austria 12. MARKETING AUTHORISATION NUMBER(S) Reg. No.: <To be completed nationally> 13. BATCH NUMBER Lot 14. GENERAL CLASSIFICATION FOR SUPPLY <To be completed nationally> 15. INSTRUCTIONS ON USE Shake before use. This product can become cloudy which, however, does not affect adversely the action. Traditional herbal medicinal product for use in mild dyspepsia (such as feeling of abdominal fullness, flatulence) and loss of appetite. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. If the symptoms persist longer than 7 days or deteriorate during the use of the medicinal product, a doctor or a pharmacist should be consulted. The recommended dose is 5 ml {(Invented) Name} 2 – 3 times/day. Read the package leaflet before use. 16. INFORMATION IN BRAILLE <to be completed nationally> [for AT only] Logo Pictogram Austrian flag Green point RIVIERA since 1923 {(Invented) name} is sugar-free PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label bottle 1. NAME OF THE MEDICINAL PRODUCT {(Invented) name <strength> pharmaceutical form} 2. STATEMENT OF ACTIVE SUBSTANCE(S) 100 ml of oral liquid contain 71.5 ml extract (as liquid extract) (equivalent to 2.01 g mixture of herbal substances) from wormwood herb, gentian root, angelica root, myrrh, dandelion root, zedoary rhizome, walnut leaves, calamus rhizome, tormentil, white horehound, valerian root, cinnamon, cardamom fruit. (66/180/328/367/260/294/260/38/50/32/54/54/27 mg) Extraction solvent: ethanol 96.3 % V/V / water (1:1) DER 1:33 - 37 3. LIST OF EXCIPIENTS Contains 38 vol % ethanol (alcohol), i.e. up to 1.5 g per dose (5 ml), equivalent to 37.5 ml beer, 15 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy. 4. PHARMACEUTICAL FORM AND CONTENTS Oral solution 50 ml 100 ml 250 ml 500 ml 1000 ml 5. METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. Oral use. With measuring cup for dosing. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY [for HR only] {(Invented) Name} should not be used in children and adolescents under 18 years. 8. EXPIRY DATE EXP Shelf life after first opening: 1 year. 9. SPECIAL STORAGE CONDITIONS Do not store above 25C after first opening. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Registration holder: RIVIERA Pharma & Cosmetics GmbH 12. MARKETING AUTHORISATION NUMBER(S) <to be completed nationally> 13. BATCH NUMBER Lot 14. GENERAL CLASSIFICATION FOR SUPPLY <To be completed nationally> 15. INSTRUCTIONS ON USE Shake before use. This product can become cloudy which, however, does not affect adversely the action. Traditional herbal medicinal product for use in mild dyspepsia (such as feeling of abdominal fullness, flatulence) and loss of appetite. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. If the symptoms persist longer than 7 days or deteriorate during the use of the medicinal product, a doctor or a pharmacist should be consulted. The recommended dose is 5 ml {(Invented) Name} 2 – 3 times/day. Read the package leaflet before use. 16. INFORMATION IN BRAILLE [for AT only] Logo Pictogram Austrian flag Green point RIVIERA SINCE 1923 <{(Invented) name}> is sugar-free .