<effectiveTime value="20260105"/> <setId root="2134d14f-3d1a-4564-9944-a47d594f031d"/> <versionNumber value="6"/> <author> <time/> <assignedEntity> <representedOrganization> <id extension="966985624" root="1.3.6.1.4.1.519.1"/> <name>Elanco US Inc.</name> <assignedEntity> <assignedOrganization/> </assignedEntity> </representedOrganization> </assignedEntity> </author> <component> <structuredBody> <component> <section> <id root="fbfac762-5797-4e25-9e4a-4412543874af"/> <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/> <effectiveTime value="20251224"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="58198-0040" codeSystem="2.16.840.1.113883.6.69"/> <name>Tylan 40</name> <formCode code="C42938" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="GRANULE"/> <asEntityWithGeneric> <genericMedicine> <name>tylosin phosphate</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator unit="g" value="40"/> <denominator unit="kg" value="0.45"/> </quantity> <ingredientSubstance> <code code="NR75X12AFF" codeSystem="2.16.840.1.113883.4.9"/> <name>tylosin phosphate</name> <activeMoiety> <activeMoiety> <code code="YEF4JXN031" codeSystem="2.16.840.1.113883.4.9"/> <name>tylosin</name> </activeMoiety> </activeMoiety> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator unit="kg" value="22.68"/> <denominator value="1"/> </quantity> <containerPackagedProduct> <code code="58198-0040-1" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43167" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BAG"/> </containerPackagedProduct> </asContent> </manufacturedProduct> <subjectOf> <approval> <id extension="NADA012491" root="2.16.840.1.113883.3.150"/> <code code="C73593" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="NADA"/> <author> <territorialAuthority> <territory> <code code="USA" codeSystem="2.16.840.1.113883.5.28"/> </territory> </territorialAuthority> </author> </approval> </subjectOf> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20100108"/> </effectiveTime> </marketingAct> </subjectOf> <consumedIn> <substanceAdministration> <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/> </substanceAdministration> </consumedIn> </manufacturedProduct> </subject> </section> </component> <component> <section ID="s1"> <id root="304359ff-cd5e-455b-93dd-d5658d1b5b80"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph>AF0040 </paragraph> <paragraph> <content styleCode="bold"> <content styleCode="italics">Elanco™</content> </content> </paragraph> <paragraph> <content styleCode="bold"> <content styleCode="italics">Tylan™40</content> </content> </paragraph> <paragraph> <content styleCode="bold">™</content> </paragraph> <paragraph> <content styleCode="bold">Net Weight: 50 lbs</content> (22.68 kg) </paragraph> <paragraph> <content styleCode="bold"> <content styleCode="italics">Tylosin Phosphate</content> </content> </paragraph> <paragraph> <content styleCode="bold">Type A Medicated Article</content> </paragraph> <paragraph> <content styleCode="bold">CAUTION:</content> Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. </paragraph> <paragraph> <content styleCode="bold">For use in Swine and Beef Cattle Feeds Only</content> </paragraph> <paragraph> <content styleCode="bold">Do Not Feed Undiluted</content> </paragraph> <paragraph>Equivalent to <content styleCode="bold">40 g</content> Tylosin per Pound </paragraph> </text> <effectiveTime value="20251224"/> </section> </component> <component> <section ID="s2"> <id root="4e98dfc6-313d-4c1b-bf59-760e9cf3406f"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>Swine:


               
                  
                     Warning: Tylan 40 may be irritating to unprotected skin and eyes. When mixing and handling Tylan 40 use protective clothing, impervious gloves and a dust respirator. In case of accidental eye exposure, flush eyes with plenty of water. Exposed skin should be washed with plenty of soap and water. Remove and wash contaminated clothing. Seek medical attention if irritation becomes severe or persists. The material safety data sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441. 
                  
                     For reduction in severity of effects of atrophic rhinitis. Feed 100 g of tylosin per ton (2.5 pounds Tylan 40 per ton) of complete feed. Feed continuously as the sole ration. 
                  
                     For control of swine dysentery. Feed 100 g of tylosin per ton (2.5 pounds Tylan 40 per ton) of complete feed for at least three weeks. Follow with 40 g tylosin per ton (1 pound Tylan 40 per ton) of complete feed until pigs reach market weight. 
                  
                     For the treatment and control of swine dysentery. Feed 40 to 100 grams of tylosin (1.0 to 2.5 pounds of Tylan 40) per ton of complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin (as Tylan Soluble) per gallon in drinking water for 3 to 10 days. 
                  
                     For control of porcine proliferative enteropathies (PPE, ileitis). Feed 100 g of tylosin per ton (2.5 pounds Tylan 40 per ton) of complete feed for 21 days. Alternatively, feed 100 g of tylosin per ton (2.5 pounds Tylan 40 per ton) of complete feed for at least three weeks, followed by 40 g tylosin per ton of complete feed until pigs reach market weight. Alternatively, feed 40 to 100 grams of tylosin (1.0 to 2.5 pounds of Tylan 40) per ton of complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin (as Tylan Soluble) per gallon in drinking water for 3 to 10 days. Feed continuously as the sole ration when feeding Tylan. 
                  
                     NOTICE: Organisms vary in their degree of susceptibility to any chemotherapeutic. If no improvement is observed after recommended treatment, diagnosis and susceptibility should be reconfirmed.
                  
                  pH must be between 4.5 and 6.0. 
                                    For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top.
Recirculate daily as described even when not used. 
                                    For liquid feeds stored in mechanical, air, or other agitation-type tank system: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top.
Agitate daily as described even when not used. 
                                    Liquid Type B Cattle Feeds must bear an expiration date of 31 days after the date of manufacture. 
                     
                     
                     
                     
                        
                           
                              
                                 Mixing and Feeding Directions for Beef Cattle Feeds
                                 
For reduction of incidence of liver abscesses in beef cattle associated with Fusobacterium necrophorum and Arcanobacterium pyogenes. 
                           
                           
                              
                                 Tylan 40 Per Ton Of Type C Feed 
                           
                           
                              Tylosin Per Ton Of Type C Feed 
                           
                        
                        
                           
                              0.2 to 0.25 Ibs 
                           
                           
                              8 to 10 g 
                           
                        
                        
                           
                              To be fed so that each animal receives not more than 90 mg per head per day and not less than 60 mg per head per day.
Feed continuously as the sole ration. 
                           
                           
                        
                        
                           
                              
                                 Mixing Directions for Liquid Type B Cattle Feeds
                              
                           
                           
                              
                                 LIMITATIONS:
                                 

                              
                              
                                 
                                    
1.
                                 2.
                                 3.
                                 4.
                              
                           
                        
                     
                  
                  
                     NOT FOR HUMAN USE
                  
                  
                     Store at Room Temperature, 25°C (77ºF). Avoid moisture.
                  
                  
                     Not to be used after the date printed on the bottom of the bag.
                  
                  
               
               
               
                  
                     Figure

Mixing and Feeding Directions for Beef Cattle Feeds For reduction of incidence of liver abscesses in beef cattle associated with Fusobacterium necrophorum and Arcanobacterium pyogenes.	Tylan 40 Per Ton Of Type C Feed	Tylosin Per Ton Of Type C Feed
	0.2 to 0.25 Ibs	8 to 10 g
	To be fed so that each animal receives not more than 90 mg per head per day and not less than 60 mg per head per day. Feed continuously as the sole ration.
Mixing Directions for Liquid Type B Cattle Feeds	LIMITATIONS: