<text/> <effectiveTime value="20231219"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="23243-2320" codeSystem="2.16.840.1.113883.6.69"/> <name>PROHIBIT<suffix>Soluble Drench Powder</suffix> </name> <formCode code="C42973" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POWDER, FOR SOLUTION"/> <asEntityWithGeneric> <genericMedicine> <name>LEVAMISOLE HYDROCHLORIDE</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIM"> <quantity> <numerator value="0.9" unit="g"/> <denominator value="1" unit="g"/> </quantity> <ingredientSubstance> <code code="DL9055K809" codeSystem="2.16.840.1.113883.4.9"/> <name>LEVAMISOLE HYDROCHLORIDE</name> <activeMoiety> <activeMoiety> <code code="2880D3468G" codeSystem="2.16.840.1.113883.4.9"/> <name>LEVAMISOLE</name> </activeMoiety> </activeMoiety> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator value="52" unit="g"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="23243-2320-5" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43199" displayName="PACKET" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> </asContent> <asContent> <quantity> <numerator value="605" unit="g"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="23243-2320-6" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43196" displayName="JUG" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> </asContent> </manufacturedProduct> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20220420"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <approval> <id extension="ANADA200225" root="2.16.840.1.113883.3.150"/> <code code="C73583" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ANADA"/> <author> <territorialAuthority> <territory> <code code="USA" codeSystem="2.16.840.1.113883.5.28"/> </territory> </territorialAuthority> </author> </approval> </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="Le7d4d372-5b0e-4189-8b19-2c7560c82745"> <id root="6a91ebbb-c3de-4f40-b845-8968182e3590"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph>NDC 23243-2320-5<br/> <content styleCode="bold">PROHIBIT®</content> <br/> <content styleCode="bold">(levamisole hydrochloride)</content> <br/> <content styleCode="bold">Soluble Drench Powder</content> <br/> <content styleCode="bold">Anthelmintic</content> <br/>Each packet contains 46.8 grams of levamisole hydrochloride activity.</paragraph> </text> <effectiveTime value="20231218"/> </section> </component> <component> <section ID="L0600d1ed-b068-41f6-9951-658971536db2"> <id root="952e5cdf-a26d-4581-8a83-3c3641f57c9b"/> <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/> <text> <paragraph> <content styleCode="bold">CATTLE AND SHEEP DEWORMER FOR ORAL USE</content> <br/>Administer as a standard drench with standard drench syringe or administer as a concentrated<br/>drench solution with an automatic drenching syringe.</paragraph> <paragraph> <content styleCode="bold">INDICATIONS:</content> <br/>Prohibit (levamisole hydrochloride) is a broad-spectrum anthelmintic and is effective against<br/>the following nematode infections in cattle and sheep:</paragraph> <paragraph> <content styleCode="bold">SHEEP:</content> <br/> <content styleCode="bold">STOMACH WORMS:</content> <content styleCode="italics"> Haemonchus contortus</content>,<content styleCode="italics"> Trichostrongylus axei</content>,<content styleCode="italics"> Teladorsagia circumcincta</content>.<br/> <content styleCode="bold">INTESTINAL WORMS: </content> <content styleCode="italics">Trichostrongylus colubriformis</content>, <content styleCode="italics">Cooperia curticei</content>, <content styleCode="italics">Nematodirus spathiger</content>,<br/> <content styleCode="italics">Bunostomum trigonocephalum</content>, <content styleCode="italics">Oesophagostomum columbianum</content>, <content styleCode="italics">Chabertia ovina</content>.<br/> <content styleCode="bold">LUNGWORMS: </content> <content styleCode="italics">Dictyocaulus filaria</content>.</paragraph> <paragraph> <content styleCode="bold">CATTLE:</content> <br/> <content styleCode="bold">STOMACH WORMS: </content> <content styleCode="italics">Haemonchus placei</content>, <content styleCode="italics">Trichostrongylus axei</content>, <content styleCode="italics">Ostertagia ostertagi</content>.<br/> <content styleCode="bold">INTESTINAL WORMS: </content> <content styleCode="italics">Trichostrongylus longispicularis</content>, <content styleCode="italics">Cooperia oncophora</content>, <content styleCode="italics">Cooperia punctata</content>,<br/> <content styleCode="italics">Nematodirus spathiger</content>, <content styleCode="italics">Bunostomum phlebotomum</content>, <content styleCode="italics">Oesophagostomum radiatum</content>.<br/> <content styleCode="bold">LUNGWORMS: </content> <content styleCode="italics">Dictyocaulus viviparus</content>.</paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="Lda9ea73f-a98a-4177-9dd3-08720de6f0c0"> <id root="59be80dc-2978-4c8e-8438-fa56c6af7a0e"/> <code code="34072-9" codeSystem="2.16.840.1.113883.6.1" displayName="GENERAL PRECAUTIONS SECTION"/> <text> <paragraph> <content styleCode="bold">NOT FOR USE IN HUMANS</content> <br/> <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN</content> <br/> <content styleCode="bold">Restricted Drug (California) Use Only as Directed</content> <br/> <content styleCode="bold">Approved by FDA under ANADA # 200-225</content> </paragraph> <paragraph> <content styleCode="bold">NET WEIGHT: 1.8 oz (52 g)</content> </paragraph> <paragraph> <content styleCode="bold">HUVEPHARMA®</content> </paragraph> <paragraph>Manufactured for Huvepharma, Inc.<br/>Peachtree City, GA 30269<br/>Made in Bulgaria<br/>®Registered Trademark of Huvepharma, Inc.</paragraph> <paragraph> <content styleCode="bold">LOT</content> </paragraph> <paragraph> <content styleCode="bold">EXP</content> </paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="Laf9ad1f0-ebd2-4a1a-9060-564b20105c85"> <id root="8e66789f-3010-470e-aefa-23911ebe2413"/> <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE & ADMINISTRATION SECTION"/> <text> <paragraph> <content styleCode="bold">DOSAGE AND ADMINISTRATION</content> </paragraph> <table cellspacing="0" cellpadding="0"> <tbody> <tr> <td colspan="3" valign="top"> <paragraph> <content styleCode="bold">CATTLE–STANDARD DRENCH SOLUTION:</content> Place the contents of this  packet in a 1 quart (32 fl. oz.) container, fill with water, swirl until dissolved. <content>Administer as a single drench dose according to the following table:</content> </paragraph> </td> <td colspan="3" valign="top"> <paragraph> <content styleCode="bold"> SHEEP–STANDARD DRENCH SOLUTION:</content> Place the contents of this  packet in a 1 gallon (128 fl. oz.) container, fill with water, swirl until dissolved. Administer as a single drench dose according to the following table:</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Weight</paragraph> </td> <td valign="top"> <paragraph>Drench dosage</paragraph> </td> <td valign="top"> <paragraph>Packet Will Treat</paragraph> </td> <td valign="top"> <paragraph> Weight</paragraph> </td> <td valign="top"> <paragraph>Drench Dosage</paragraph> </td> <td valign="top"> <paragraph>Packet Will Treat</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> 200 lb.</paragraph> </td> <td valign="top"> <paragraph>1/2 fl. oz.</paragraph> </td> <td valign="top"> <paragraph>64 head</paragraph> </td> <td valign="top"> <paragraph> 50 lb.</paragraph> </td> <td valign="top"> <paragraph>1/2 fl. oz.</paragraph> </td> <td valign="top"> <paragraph>256 head</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> 400 lb.</paragraph> </td> <td valign="top"> <paragraph>1 fl. oz.</paragraph> </td> <td valign="top"> <paragraph>32 head</paragraph> </td> <td valign="top"> <paragraph> 100 lb.</paragraph> </td> <td valign="top"> <paragraph>1 fl. oz.</paragraph> </td> <td valign="top"> <paragraph>128 head</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> 650 lb.</paragraph> </td> <td valign="top"> <paragraph>1 1/2 fl. oz.</paragraph> </td> <td valign="top"> <paragraph>21 head</paragraph> </td> <td valign="top"> <paragraph> 150 lb.</paragraph> </td> <td valign="top"> <paragraph>1 1/2 fl. oz.</paragraph> </td> <td valign="top"> <paragraph>84 head</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> 800 lb.</paragraph> </td> <td valign="top"> <paragraph>2 fl. oz.</paragraph> </td> <td valign="top"> <paragraph>16 head</paragraph> </td> <td valign="top"> <paragraph> 200 lb.</paragraph> </td> <td valign="top"> <paragraph>2 fl. oz.</paragraph> </td> <td valign="top"> <paragraph>64 head</paragraph> </td> </tr> </tbody> </table> <table cellspacing="0" cellpadding="0"> <tbody> <tr styleCode="First Last"> <td valign="top"> <paragraph> <content styleCode="bold"> CONCENTRATED DRENCH SOLUTION:</content> For use with automatic syringe.   Place the contents of this packet in a standard household measuring container   and add water to the 8 3/4 fl. oz. level; or use the measuring container   available from your supplier and add water to the mark. Swirl until dissolved.   Give 2 ml (milliliter) per 100 lb. body weight. Refer to the table above for the   number of cattle this packet will treat.</paragraph> </td> <td valign="top"> <paragraph> <content styleCode="bold"> CONCENTRATED DRENCH SOLUTION:</content> For use with   automatic syringe. Place the contents of this packet in a   standard household measuring container and add water to the   17 1/2 fl. oz. level. Swirl until dissolved. Give 2 ml per 50 lb.   body weight. Refer to the table above for the number of sheep   this packet will treat.</paragraph> </td> </tr> </tbody> </table> <paragraph>Do not underdose. Ensure each animal receives a complete dose based on a current body weight.<br/>Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.</paragraph> <paragraph> <content styleCode="bold">NOTE:</content> Careful weight estimates are essential for proper performance of this product. Prepare solutions<br/>as needed. However, excess solutions may be stored in clean closed containers up to 90 days without<br/>loss of anthelmintic activity. Cattle and Sheep maintained under conditions of constant helminth<br/>exposure may require re-treatment within two to four weeks after the first treatment.</paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="L740e3a35-f9a6-434c-ad75-912023ea403f"> <id root="be8ac29c-4b2d-452f-b145-c0a5500468ec"/> <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/> <text> <paragraph> <content styleCode="bold">RESIDUE WARNING: </content> <content styleCode="bold">Do not administer to cattle within 48 hours of slaughter for food. Do</content> <br/> <content styleCode="bold">not administer to sheep within 72 hours of slaughter for food. To prevent residues in milk,</content> <br/> <content styleCode="bold">do not administer to dairy animals of breeding age.</content> </paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="L01423b3c-3c8f-4c55-a62f-ab0947d08fb2"> <id root="479fbcb4-3b34-4cca-aa69-6dff29ad03d3"/> <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/> <text> <paragraph> <content styleCode="bold">OTHER WARNINGS:</content> Parasite resistance may develop to any dewormer, and has been<br/>reported for most classes of dewormers. Treatment with a dewormer used in<br/>conjunction with parasite management practices appropriate to the geographic<br/>area and the animal(s) to be treated may slow the development of parasite<br/>resistance. Fecal examinations or other diagnostic tests and parasite<br/>management history should be used to determine if the product is appropriate<br/>for the herd/flock, prior to the use of any dewormer. Following the use of any<br/>dewormer, effectiveness of treatment should be monitored (for example, with<br/>the use of a fecal egg count reduction test or another appropriate method).<br/>A decrease in a drug's effectiveness over time as calculated by fecal egg<br/>count reduction tests may indicate the development of resistance to the<br/>dewormer administered. Your parasite management plan should be adjusted<br/>accordingly based on regular monitoring.</paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="Ldde1d767-a7b2-4ce0-8acb-bc1187a6bc0f"> <id root="f9038478-c804-498c-8924-bb9c81a8f1ea"/> <code code="34072-9" codeSystem="2.16.840.1.113883.6.1" displayName="GENERAL PRECAUTIONS SECTION"/> <text> <paragraph> <content styleCode="bold">CAUTION:</content> Muzzle foam may be observed. However, this reaction will<br/>disappear within a few hours. If this condition persists, a veterinarian<br/>should be consulted. Follow recommended dosage carefully. Consult<br/>veterinarian before using in severely debilitated animals.<br/> <content styleCode="bold">Consult your veterinarian for assistance in the diagnosis, treatment,</content> <br/> <content styleCode="bold">and control of parasitism.</content> </paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="L3222c337-b626-4b7a-ac60-ab7314f0d160"> <id root="743e7c58-e7ff-460c-a90d-11a4e9f21669"/> <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/> <text> <paragraph> <content styleCode="bold">CONTACT INFORMATION</content> </paragraph> <paragraph>To report suspected adverse drug events, for technical assistance or to<br/>obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc.<br/>at 1-877-994-4883 or www.huvepharma.us. For additional information about<br/>adverse drug experience reporting for animal drugs, contact FDA at<br/>1-888-FDA-VETS or http://www.fda.gov/reportanimalae.</paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="L1afcd327-2326-4e99-b733-4bec4bc97e0d"> <id root="daf6eebd-46cd-470b-adda-b10abe4a47c3"/> <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/> <text> <paragraph>Store between 20–25ºC (68-77ºF).    <br/> <content styleCode="bold">HOW SUPPLIED:</content> 52 g (1.8 oz) and 605 g (21.34 oz)</paragraph> <paragraph> <renderMultiMedia referencedObject="L753e251d-3750-41ba-9dbb-4d3d69bd4e62"/> </paragraph> </text> <effectiveTime value="20240528"/> <component> <observationMedia ID="L753e251d-3750-41ba-9dbb-4d3d69bd4e62"> <text>Take Time</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="Take Time.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="La527506a-af6c-4a81-9547-352990cfee3d"> <id root="0c0ec2af-168b-4eb7-a733-f071200d9d05"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph>NDC 23243-2320-6<br/> <content styleCode="bold">PROHIBIT®</content> <br/> <content styleCode="bold">(levamisole hydrochloride)</content> <br/> <content styleCode="bold">Soluble Drench Powder</content> <br/> <content styleCode="bold">Anthelmintic</content> </paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="L362b2a1e-e333-4434-924b-36fb9473fde0"> <id root="ce923776-79a3-4783-99b7-1192d53c1824"/> <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/> <text> <paragraph> <content styleCode="bold">CATTLE AND SHEEP DEWORMER </content> <content styleCode="bold">FOR ORAL USE</content> <br/> <content styleCode="bold">This bottle contains 544.5 grams of </content> <content styleCode="bold">levamisole hydrochloride activity.</content> </paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="L17c16e0e-3b90-484b-bde9-fa328108d437"> <id root="6f30d878-5a07-446b-a43c-a577eb19eaa7"/> <code code="34072-9" codeSystem="2.16.840.1.113883.6.1" displayName="GENERAL PRECAUTIONS SECTION"/> <text> <paragraph> <content styleCode="bold">Not For Use in Humans</content> </paragraph> <paragraph> <content styleCode="bold">Keep Out of Reach of Children</content> </paragraph> <paragraph> <content styleCode="bold">Restricted Drug (California) - </content> <content styleCode="bold">Use Only as Directed</content> </paragraph> <paragraph> <content styleCode="bold">Approved by FDA under ANADA # 200-225</content> </paragraph> <paragraph> <content styleCode="bold">Net Wt: 21.34 oz (1.3 lb.) (605 g)</content> </paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="Ldc5e119b-0eab-424c-bcb9-9524d31dbea6"> <id root="cb5772b4-1f34-4541-b320-7ecc94bea310"/> <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/> <text> <paragraph> <content styleCode="bold">INDICATIONS:</content> PROHIBIT (levamisole hydrochloride) is a broad-spectrum anthelmintic and is<br/>effective against the following nematode infections in cattle and sheep:<br/> <content styleCode="bold">SHEEP:</content> <br/> <content styleCode="bold">STOMACH WORMS: </content> <content styleCode="italics">Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta</content>.<br/> <content styleCode="bold">INTESTINAL WORMS: </content> <content styleCode="italics">Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger,</content> <br/> <content styleCode="italics">Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina</content>.<br/> <content styleCode="bold">LUNGWORMS: </content> <content styleCode="italics">Dictyocaulus filaria</content>.<br/> <content styleCode="bold">CATTLE:</content> <br/> <content styleCode="bold">STOMACH WORMS: </content> <content styleCode="italics">Haemonchus placei, Trichostrongylus axei, Ostertagia ostertagi</content>.<br/> <content styleCode="bold">INTESTINAL WORMS: </content> <content styleCode="italics">Trichostrongylus longispicularis, Cooperia oncophora, Cooperia punctata,</content> <br/> <content styleCode="italics">Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum</content>.<br/> <content styleCode="bold">LUNGWORMS</content>: <content styleCode="italics">Dictyocaulus viviparus</content>.</paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="L25f7dece-a1a7-40f1-b589-7a34654afe95"> <id root="8d7eb23c-736c-4ec8-9c23-b84975ac8186"/> <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/> <text> <paragraph> <content styleCode="bold">RESIDUE WARNING: </content> <content styleCode="bold">Do not administer to cattle within 48 hours of slaughter</content> <br/> <content styleCode="bold">for food. Do not administer to sheep within 72 hours of slaughter for food. To</content> <br/> <content styleCode="bold">prevent residues in milk, do not administer to dairy animals of breeding age.</content> </paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="Lf7de1872-dd76-4f1f-a529-1e602e3206bd"> <id root="9d3570ca-1602-4e35-96bf-7bcdc622671d"/> <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/> <text> <paragraph> <content styleCode="bold">OTHER WARNINGS:</content> Parasite resistance may develop to any dewormer, and has been reported<br/>for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite<br/>management practices appropriate to the geographic area and the animal(s) to be treated may<br/>slow the development of parasite resistance. Fecal examinations or other diagnostic tests and<br/>parasite management history should be used to determine if the product is appropriate for the<br/>herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness<br/>of treatment should be monitored (for example, with the use of a fecal egg count reduction<br/>test or another appropriate method). A decrease in a drug's effectiveness over time as<br/>calculated by fecal egg count reduction tests may indicate the development of resistance to<br/>the dewormer administered. Your parasite management plan should be adjusted accordingly<br/>based on regular monitoring.</paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="L8be63762-e40c-4776-9e65-0f1889a0532b"> <id root="515dbee3-03ee-4225-a490-e1c6a159fe8b"/> <code code="34072-9" codeSystem="2.16.840.1.113883.6.1" displayName="GENERAL PRECAUTIONS SECTION"/> <text> <paragraph> <content styleCode="bold">CAUTION:</content> Muzzle foam may be observed. However, this reaction will disappear within a few<br/>hours. If this condition persists, a veterinarian should be consulted. Follow recommended<br/>dosage carefully. Consult veterinarian before using in severely debilitated animals.</paragraph> <paragraph> <content styleCode="bold">Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.</content> </paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="L5dbb7cc4-ac4a-4639-86af-d6d62e510ec0"> <id root="4ae74637-0264-4302-aa94-ee976c912eaa"/> <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/> <text> <paragraph>Store between 20º-25ºC (68º-77ºF).</paragraph> <paragraph>HOW SUPPLIED: 52 g (1.8 oz) and 605 g (21.34 oz)</paragraph> <paragraph>®Registered trademark of Huvepharma, Inc.<br/>Manufactured for<br/>Huvepharma, Inc.<br/>Peachtree City, GA 30269<br/>Made in Bulgaria</paragraph> <paragraph> <content styleCode="bold">LOT NO.:                  EXP. DATE</content> </paragraph> <paragraph> <renderMultiMedia referencedObject="Lddd24718-5d9c-4e5a-b82f-5ded95ee73d1"/> </paragraph> </text> <effectiveTime value="20240528"/> <component> <observationMedia ID="Lddd24718-5d9c-4e5a-b82f-5ded95ee73d1"> <text>Take Time</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="Take Time 2.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="L94a654d2-77ac-4a01-aea8-2cbf432f2700"> <id root="90d03132-38cb-439e-94ba-abc9291cc0f7"/> <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE & ADMINISTRATION SECTION"/> <text> <paragraph> <content styleCode="bold">DOSAGE AND ADMINISTRATION:</content> When you are ready to deworm your cattle or sheep, add water to the powder in this bottle up to the 3 liter mark. Swirl to mix thoroughly before using. If any solution is left over, it may be stored for up to 3 months in this tightly capped bottle, shake well before using.</paragraph> <paragraph> <content styleCode="bold">DATE WATER WAS ADDED TO THIS BOTTLE</content> </paragraph> <paragraph> <content styleCode="bold">                                                Month       Day       Year</content> </paragraph> <table cellspacing="0" cellpadding="0"> <tbody> <tr> <td colspan="3" valign="top"> <paragraph>Administer as a single drench dose as follows:</paragraph> <paragraph> <content styleCode="bold">CATTLE--2 mL per 100 lb. body weight</content> </paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Weight</paragraph> </td> <td valign="top"> <paragraph>Drench dosage</paragraph> </td> <td valign="top"> <paragraph>Bottle</paragraph> <paragraph>Will Treat</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>100 lb.</paragraph> </td> <td valign="top"> <paragraph>2 mL</paragraph> </td> <td valign="top"> <paragraph>1,500 head</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>300 lb.</paragraph> </td> <td valign="top"> <paragraph>6 mL</paragraph> </td> <td valign="top"> <paragraph>500 head</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>500 lb.</paragraph> </td> <td valign="top"> <paragraph>10 mL</paragraph> </td> <td valign="top"> <paragraph>300 head</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>700 lb.</paragraph> </td> <td valign="top"> <paragraph>14 mL</paragraph> </td> <td valign="top"> <paragraph>214 head</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>1,000 lb.</paragraph> </td> <td valign="top"> <paragraph>20 mL</paragraph> </td> <td valign="top"> <paragraph>150 head</paragraph> </td> </tr> <tr> <td colspan="3" valign="top"> <paragraph> <content styleCode="bold">SHEEP--1 mL per 50 lb. body weight</content> </paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>Weight</paragraph> </td> <td valign="top"> <paragraph>Drench dosage</paragraph> </td> <td valign="top"> <paragraph>Bottle</paragraph> <paragraph>Will Treat</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>50 lb.</paragraph> </td> <td valign="top"> <paragraph>1 mL</paragraph> </td> <td valign="top"> <paragraph>3,000 head</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>100 lb.</paragraph> </td> <td valign="top"> <paragraph>2 mL</paragraph> </td> <td valign="top"> <paragraph>1,500 head</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>150 lb.</paragraph> </td> <td valign="top"> <paragraph>3 mL</paragraph> </td> <td valign="top"> <paragraph>1,000 head</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>200 lb.</paragraph> </td> <td valign="top"> <paragraph>4 mL</paragraph> </td> <td valign="top"> <paragraph>750 head</paragraph> </td> </tr> </tbody> </table> <paragraph>Do not underdose. Ensure each animal receives a complete dose based on a current body weight.<br/>Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.</paragraph> <paragraph> <content styleCode="bold">NOTE:</content> Careful weight estimates are essential for proper performance of this<br/>product. Cattle and sheep maintained under conditions of constant helminth<br/>exposure may require retreatment within two to four weeks after the first<br/>treatment.</paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="L505d1d63-9efc-4cb1-a426-6748194b651d"> <id root="70211c49-da20-49cd-9f6a-2a4a378c7033"/> <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/> <text> <paragraph> <content styleCode="bold">CONTACT INFORMATION</content> </paragraph> <paragraph>To report suspected adverse drug events, for technical assistance or to<br/>obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at<br/>1-877-994-4883 or www.huvepharma.us. For additional information about<br/>adverse drug experience reporting for animal drugs, contact FDA at<br/>1-888-FDA-VETS or http://www.fda.gov/reportanimalae.</paragraph> </text> <effectiveTime value="20240524"/> </section> </component> <component> <section ID="L47115d9a-552e-4f9e-a848-9e259ac636de"> <id root="80bf3aab-ca68-43c4-9b0e-cc6ac849df4c"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <text> <paragraph> <renderMultiMedia referencedObject="L06fc673f-f905-4e95-aa40-543cd3fe53a1"/> </paragraph> <paragraph> <renderMultiMedia referencedObject="Ld8dc69b0-bdce-438c-a0c5-3b6e2a5fa590"/> </paragraph> <paragraph> <renderMultiMedia referencedObject="L7dea1bbd-f022-4171-b5ed-c8f823251d15"/> </paragraph> </text> <effectiveTime value="20240528"/> <component> <observationMedia ID="L06fc673f-f905-4e95-aa40-543cd3fe53a1"> <text>Prohibit 52 g booklet 0324_Page 1</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="Prohibit 52 g booklet 0324_Page_1.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="Ld8dc69b0-bdce-438c-a0c5-3b6e2a5fa590"> <text>Prohibit 52 g booklet 0324_Page 2</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="Prohibit 52 g booklet 0324_Page_2.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="L7dea1bbd-f022-4171-b5ed-c8f823251d15"> <text>Prohibit 52 g booklet 0324 Base</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="Prohibit 52 g booklet 0324_Page_3.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="L1ec6060d-2970-4bbd-b08d-52ec5db1b5d4"> <id root="f7aa5b3c-f935-41f8-b8a0-e45591ae531c"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <text> <paragraph> <renderMultiMedia referencedObject="L34b3e870-c2cd-4350-8a36-0bf62263756b"/> </paragraph> </text> <effectiveTime value="20240528"/> <component> <observationMedia ID="L34b3e870-c2cd-4350-8a36-0bf62263756b"> <text>HVP_Prohibit_605 g_03-2022</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="Prohibit bottle label 605 g 0324.jpg"/> </value> </observationMedia> </component> </section> </component> </structuredBody> </component> </document>