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<p class="DocumentTitle"><strong>TUSSNEX FM <span class="product-label-link" type="condition" conceptid="255573" conceptname="Chronic obstructive lung disease">COLD</span> AND SINUS- acetaminophen, guaifenesin and phenylephrine hydrochloride liquid </strong><br>Guardian Drug Company<br></p>
<p class="disclaimer">Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.</p>
</div>
<h1>  Maximum strength Tussnex FM <span class="product-label-link" type="condition" conceptid="260427" conceptname="Common cold">Cold</span> and Sinus
</h1>
<div class="Contents">
<div class="Section" data-sectionCode="48780-1">
<a name="section-1"></a><p></p>
<h1></h1>
</div>
<div class="Section" data-sectionCode="55106-9">
<a name="L5d8f3b11-f2c9-4571-9c67-369be914062a"></a><a name="section-1"></a><p></p>
<h1>Active ingredients (in each 20 mL)</h1>
<p class="First">Acetaminophen 650 mg</p>
<p>Guaifenesin 400 mg</p>
<p>Phenylephrine HCl 10 mg</p>
</div>
<div class="Section" data-sectionCode="55105-1">
<a name="L51f818f4-5c6a-4add-a82b-faa57176a405"></a><a name="section-2"></a><p></p>
<h1>Purpose</h1>
<p class="First"><span class="product-label-link" type="condition" conceptid="4329041" conceptname="Pain">Pain</span> reliever/<span class="product-label-link" type="condition" conceptid="437663" conceptname="Fever">fever</span> reducer</p>
<p>Expectorant</p>
<p>Nasal decongestant</p>
</div>
<div class="Section" data-sectionCode="50565-1">
<a name="L600fd0cb-7ab7-41a9-b58b-de3378052f47"></a><a name="section-3"></a><p></p>
<h1></h1>
</div>
<div class="Section" data-sectionCode="34067-9">
<a name="L22533ebd-e06e-4f29-92a9-754984b86953"></a><a name="section-4"></a><p></p>
<h1>Uses</h1>
<ul>
<li>temporarily relieves these <span class="product-label-link" type="condition" conceptid="260427" conceptname="Common cold">common cold</span> and <span class="product-label-link" type="condition" conceptid="4266367" conceptname="Influenza">flu symptoms</span>:</li>
<li><span class="product-label-link" type="condition" conceptid="4195085" conceptname="Nasal congestion">nasal congestion</span></li>
<li><span class="product-label-link" type="condition" conceptid="4220211" conceptname="Congestion of nasal sinus">sinus congestion</span> and pressure</li>
<li>minor <span class="product-label-link" type="condition" conceptid="4329041" conceptname="Pain">aches</span> and <span class="product-label-link" type="condition" conceptid="4329041" conceptname="Pain">pains</span></li>
<li><span class="product-label-link" type="condition" conceptid="26711" conceptname="Chronic pharyngitis">sore throat</span></li>
<li><span class="product-label-link" type="condition" conceptid="378253" conceptname="Headache">headache</span></li>
<li>temporarily reduces <span class="product-label-link" type="condition" conceptid="437663" conceptname="Fever">fever</span></li>
<li>helps loosen <span class="product-label-link" type="condition" conceptid="4102774" conceptname="Productive cough">phlegm</span> (mucus) and thin bronchial secretions to drain bronchial tubes and make <span class="product-label-link" type="condition" conceptid="254761" conceptname="Cough">coughs</span> more productive</li>
</ul>
</div>
<div class="Section" data-sectionCode="34071-1">
<a name="L4755787b-7614-4a7f-a78d-27619871f086"></a><a name="section-5"></a><p></p>
<h1>Warnings</h1>
<ul>
<li>
<span class="Bold">Liver warning:</span> This product contains acetaminophen. Severe <span class="product-label-link" type="condition" conceptid="4352876" conceptname="Liver damage">liver damage</span> may occur if you take:</li>
<li>more than 6 doses in 24 hours, which is maximum daily amount</li>
<li>with other drugs containing acetaminophen</li>
<li>3 or more alcoholic drinks daily while using this product</li>
<li>
<span class="Bold"><span class="product-label-link" type="condition" conceptid="26711" conceptname="Chronic pharyngitis">Sore throat</span> warning:</span> if <span class="product-label-link" type="condition" conceptid="26711" conceptname="Chronic pharyngitis">sore throat</span> is severe, persists for more than 2 days, is accompanied or followed by <span class="product-label-link" type="condition" conceptid="437663" conceptname="Fever">fever</span>, <span class="product-label-link" type="condition" conceptid="378253" conceptname="Headache">headache</span>, <span class="product-label-link" type="condition" conceptid="140214" conceptname="Eruption">rash</span>, <span class="product-label-link" type="condition" conceptid="31967" conceptname="Nausea">nausea</span>, <span class="product-label-link" type="condition" conceptid="441408" conceptname="Vomiting">vomiting</span>, consult a doctor promptly.</li>
</ul>
<div class="Section" data-sectionCode="50570-1">
<a name="Le85fbc92-4584-4919-a84c-3a8ced6f90f9"></a><a name="section-5.1"></a><p></p>
<h2>Do not use</h2>
<ul>
<li>
<span class="Bold">with any other drug containing acetaminophen</span> (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.</li>
<li>for children under 12 years of age</li>
<li>if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for <span class="product-label-link" type="condition" conceptid="438727" conceptname="Atypical depressive disorder">depression</span>, psychiatric, or emotional conditions or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.</li>
</ul>
<div class="Section" data-sectionCode="50569-3">
<a name="L134b9ff1-df38-46cf-978d-7ea577fd2e5e"></a><a name="section-5.1.1"></a><p></p>
<h3>Ask a doctor before use if you have</h3>
<ul>
<li>liver disease</li>
<li>heart disease</li>
<li>high blood pressure</li>
<li>thyroid disease</li>
<li><span class="product-label-link" type="condition" conceptid="201820" conceptname="Diabetes mellitus">diabetes</span></li>
<li>trouble urinating due to an <span class="product-label-link" type="condition" conceptid="4093346" conceptname="Large prostate">enlarged prostate</span> gland</li>
<li>persistent or <span class="product-label-link" type="condition" conceptid="254761" conceptname="Cough">chronic cough</span> such as occurs with smoking, <span class="product-label-link" type="condition" conceptid="317009" conceptname="Asthma">asthma</span>, <span class="product-label-link" type="condition" conceptid="255841" conceptname="Chronic bronchitis">chronic bronchitis</span> or <span class="product-label-link" type="condition" conceptid="4169883" conceptname="Emphysema">emphysema</span></li>
<li><span class="product-label-link" type="condition" conceptid="254761" conceptname="Cough">cough</span> that occurs with too much <span class="product-label-link" type="condition" conceptid="4102774" conceptname="Productive cough">phlegm</span> (mucus)</li>
</ul>
<div class="Section" data-sectionCode="50568-5">
<a name="Ladbd418c-b5ef-4a83-b5cd-cd13438dafda"></a><a name="section-5.1.1.1"></a><p></p>
<h4>Ask a doctor or pharmacist before use if</h4>
<ul><li>you are taking the blood thinning drug warfarin</li></ul>
<div class="Section" data-sectionCode="50567-7">
<a name="L08161d8b-82e9-4d56-95f6-e8c659d013f6"></a><a name="section-5.1.1.1.1"></a><p></p>
<h5>When using this product</h5>
<ul><li><span class="Bold">do not use more than directed</span></li></ul>
<div class="Section" data-sectionCode="50566-9">
<a name="L1d2b8f37-13dd-421b-9689-32b0b2355c56"></a><a name="section-5.1.1.1.1.1"></a><p></p>
<h6>Stop use and ask a doctor if</h6>
<ul>
<li><span class="product-label-link" type="condition" conceptid="436817" conceptname="Feeling nervous">nervousness</span>, <span class="product-label-link" type="condition" conceptid="4223938" conceptname="Dizziness">dizziness</span> or <span class="product-label-link" type="condition" conceptid="436962" conceptname="Insomnia">sleeplessness</span> occur</li>
<li><span class="product-label-link" type="condition" conceptid="4329041" conceptname="Pain">pain</span>, <span class="product-label-link" type="condition" conceptid="4195085" conceptname="Nasal congestion">nasal congestion</span> or <span class="product-label-link" type="condition" conceptid="254761" conceptname="Cough">cough</span> gets worse or lasts more than 7 days</li>
<li><span class="product-label-link" type="condition" conceptid="437663" conceptname="Fever">fever</span> gets worse or lasts more than 3 days</li>
<li><span class="product-label-link" type="condition" conceptid="137193" conceptname="Erythema">redness</span> or <span class="product-label-link" type="condition" conceptid="4275722" conceptname="Swelling">swelling</span> is present</li>
<li>new symptoms occur</li>
<li><span class="product-label-link" type="condition" conceptid="254761" conceptname="Cough">cough</span> comes back, or occurs with <span class="product-label-link" type="condition" conceptid="140214" conceptname="Eruption">rash</span> or persistent <span class="product-label-link" type="condition" conceptid="378253" conceptname="Headache">headache</span>. These could be signs of a serious condition.</li>
</ul>
<div class="Section" data-sectionCode="53414-9">
<a name="Ld0da3a66-2d93-4b23-bd20-adec08bae3f4"></a><a name="section-5.1.1.1.1.1.1"></a><p></p>
<h7>If pregnant or breast-feeding,</h7><p class="First">ask a health professional before use. <span class="Bold">Keep out of reach of children.</span></p>
<p><span class="Bold"><span class="product-label-link" type="condition" conceptid="4208104" conceptname="Drug overdose">Overdose</span> warning:</span> Taking more than the recommended dose (<span class="product-label-link" type="condition" conceptid="4208104" conceptname="Drug overdose">overdose</span>) may cause <span class="product-label-link" type="condition" conceptid="4352876" conceptname="Liver damage">liver damage</span>. In case of <span class="product-label-link" type="condition" conceptid="4208104" conceptname="Drug overdose">overdose</span>, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.</p>
</div>
</div>
</div>
</div>
</div>
</div>
</div>
<div class="Section" data-sectionCode="34068-7">
<a name="Lf9c98f80-c12e-4c96-9b8f-15747b6c4fa6"></a><a name="section-6"></a><p></p>
<h1>Directions</h1>
<ul>
<li><span class="Bold">do not take more than directed (see <span class="product-label-link" type="condition" conceptid="4208104" conceptname="Drug overdose">overdose</span> warning)</span></li>
<li>do not take more than 6 doses in any 24 hour period</li>
<li>measure only with dosing cup provided</li>
<li>do not use dosing cup with other products</li>
<li>dose as follows or as directed by a doctor</li>
<li>
<span class="Bold">Adults and children 12 years and older:</span> 20 mL in dosing cup provided every 4 hours.</li>
<li>
<span class="Bold">Children under 12 years of age:</span> Do not use</li>
</ul>
</div>
<div class="Section" data-sectionCode="44425-7">
<a name="L2c00a542-0fc3-4166-90f0-a1826660aeb1"></a><a name="section-7"></a><p></p>
<h1>Other information</h1>
<ul>
<li>each 20 mL contains: sodium 20 mg</li>
<li>store between 15-30<span class="Sup">o</span>C(59-86<span class="Sup">o</span>F)</li>
<li>do not refrigerate</li>
<li>dosing cup provided</li>
</ul>
</div>
<div class="Section" data-sectionCode="51727-6">
<a name="L051e619b-f27a-45fe-9031-3f6a8c42a7e2"></a><a name="section-8"></a><p></p>
<h1>Inactive ingredients</h1>
<p class="First">citric acid anhydrous, edetate disodium, FD and C blue 1, FD and C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum</p>
</div>
<div class="Section" data-sectionCode="51945-4">
<a name="Ld2f15907-78a9-4d71-ab46-fc498bfc1872"></a><a name="section-9"></a><p></p>
<h1>PDP</h1>
<p class="First">Compare to the active ingredients in Mucinex Fast Max <span class="product-label-link" type="condition" conceptid="260427" conceptname="Common cold">Cold</span> and Sinus</p>
<p>Maxumum Strength Tussnex FM</p>
<p><span class="product-label-link" type="condition" conceptid="260427" conceptname="Common cold">Cold</span> and Sinus</p>
<p>Acetaminophen </p>
<p><span class="product-label-link" type="condition" conceptid="4329041" conceptname="Pain">Pain</span> reliever/<span class="product-label-link" type="condition" conceptid="437663" conceptname="Fever">Fever</span> reducer</p>
<p>Guaifenesin</p>
<p>Expectorant</p>
<p>Phenylephrine HCl</p>
<p>Nasal Decongestant</p>
<p>Multi-symptom</p>
<p>Relieves <span class="product-label-link" type="condition" conceptid="4329041" conceptname="Pain">Pain</span> and Reduces <span class="product-label-link" type="condition" conceptid="437663" conceptname="Fever">Fever</span></p>
<p>Relieves Nasal and chest congestion</p>
<p>Thins and loosens mucus</p>
<p>For ages 12 and over<img alt="SN" src="http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=04c6bb6a-d2f8-4322-afba-e240e8090176&amp;name=GDC%20616F.jpg"></p>
<p><img alt="NM" src="http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=04c6bb6a-d2f8-4322-afba-e240e8090176&amp;name=GDC%20616B.jpg"></p>
</div>
</div>
<div class="DataElementsTables">
<table class="contentTablePetite" cellSpacing="0" cellPadding="3" width="100%"><tbody>
<tr><td class="contentTableTitle">
<strong>TUSSNEX FM <span class="product-label-link" type="condition" conceptid="255573" conceptname="Chronic obstructive lung disease">COLD</span> AND SINUS 		
					</strong><br><span class="contentTableReg">acteaminophen, guaifenesin, phenylephrine hcl liquid</span>
</td></tr>
<tr><td><table width="100%" cellpadding="5" cellspacing="0" class="formTablePetite">
<tr><td colspan="4" class="formHeadingTitle">Product Information</td></tr>
<tr class="formTableRowAlt">
<td class="formLabel">Product Type</td>
<td class="formItem">HUMAN OTC DRUG LABEL</td>
<td class="formLabel">Item Code (Source)</td>
<td class="formItem">NDC:53041-616</td>
</tr>
<tr class="formTableRow">
<td width="30%" class="formLabel">Route of Administration</td>
<td class="formItem">ORAL</td>
<td width="30%" class="formLabel">DEA Schedule</td>
<td class="formItem">    
							</td>
</tr>
</table></td></tr>
<tr><td><table width="100%" cellpadding="3" cellspacing="0" class="formTablePetite">
<tr><td colspan="3" class="formHeadingTitle">Active Ingredient/Active Moiety</td></tr>
<tr>
<th class="formTitle" scope="col">Ingredient Name</th>
<th class="formTitle" scope="col">Basis of Strength</th>
<th class="formTitle" scope="col">Strength</th>
</tr>
<tr class="formTableRowAlt">
<td class="formItem">
<strong>ACETAMINOPHEN</strong> (ACETAMINOPHEN) </td>
<td class="formItem">ACETAMINOPHEN</td>
<td class="formItem">650 mg  in 20 mL</td>
</tr>
<tr class="formTableRow">
<td class="formItem">
<strong>GUAIFENESIN</strong> (GUAIFENESIN) </td>
<td class="formItem">GUAIFENESIN</td>
<td class="formItem">400 mg  in 20 mL</td>
</tr>
<tr class="formTableRowAlt">
<td class="formItem">
<strong>PHENYLEPHRINE HYDROCHLORIDE</strong> (PHENYLEPHRINE) </td>
<td class="formItem">PHENYLEPHRINE HYDROCHLORIDE</td>
<td class="formItem">10 mg  in 20 mL</td>
</tr>
</table></td></tr>
<tr><td><table width="100%" cellpadding="3" cellspacing="0" class="formTablePetite">
<tr><td colspan="2" class="formHeadingTitle">Inactive Ingredients</td></tr>
<tr>
<th class="formTitle" scope="col">Ingredient Name</th>
<th class="formTitle" scope="col">Strength</th>
</tr>
<tr class="formTableRowAlt">
<td class="formItem"><strong>ANHYDROUS CITRIC ACID</strong></td>
<td class="formItem"> </td>
</tr>
<tr class="formTableRow">
<td class="formItem"><strong>EDETATE DISODIUM</strong></td>
<td class="formItem"> </td>
</tr>
<tr class="formTableRowAlt">
<td class="formItem"><strong>FD&amp;C BLUE NO. 1</strong></td>
<td class="formItem"> </td>
</tr>
<tr class="formTableRow">
<td class="formItem"><strong>FD&amp;C RED NO. 40</strong></td>
<td class="formItem"> </td>
</tr>
<tr class="formTableRowAlt">
<td class="formItem"><strong>GLYCERIN</strong></td>
<td class="formItem"> </td>
</tr>
<tr class="formTableRow">
<td class="formItem"><strong>PROPYLENE GLYCOL</strong></td>
<td class="formItem"> </td>
</tr>
<tr class="formTableRowAlt">
<td class="formItem"><strong>PROPYL GALLATE</strong></td>
<td class="formItem"> </td>
</tr>
<tr class="formTableRow">
<td class="formItem"><strong>WATER</strong></td>
<td class="formItem"> </td>
</tr>
<tr class="formTableRowAlt">
<td class="formItem"><strong>SODIUM BENZOATE</strong></td>
<td class="formItem"> </td>
</tr>
<tr class="formTableRow">
<td class="formItem"><strong>SODIUM CITRATE</strong></td>
<td class="formItem"> </td>
</tr>
<tr class="formTableRowAlt">
<td class="formItem"><strong>SORBITOL</strong></td>
<td class="formItem"> </td>
</tr>
<tr class="formTableRow">
<td class="formItem"><strong>SUCRALOSE</strong></td>
<td class="formItem"> </td>
</tr>
<tr class="formTableRowAlt">
<td class="formItem"><strong>XANTHAN GUM</strong></td>
<td class="formItem"> </td>
</tr>
</table></td></tr>
<tr><td><table width="100%" cellpadding="3" cellspacing="0" class="formTablePetite">
<tr><td colspan="4" class="formHeadingTitle">Product Characteristics</td></tr>
<tr class="formTableRowAlt">
<td class="formLabel">Color</td>
<td class="formItem">blue</td>
<td class="formLabel">Score</td>
<td class="formItem">    </td>
</tr>
<tr class="formTableRow">
<td class="formLabel">Shape</td>
<td class="formItem"></td>
<td class="formLabel">Size</td>
<td class="formItem"></td>
</tr>
<tr class="formTableRowAlt">
<td class="formLabel">Flavor</td>
<td class="formItem"></td>
<td class="formLabel">Imprint Code</td>
<td class="formItem"></td>
</tr>
<tr class="formTableRow">
<td class="formLabel">Contains</td>
<td class="formItem">    </td>
</tr>
</table></td></tr>
<tr><td><table width="100%" cellpadding="3" cellspacing="0" class="formTablePetite">
<tr><td colspan="5" class="formHeadingTitle">Packaging</td></tr>
<tr>
<th scope="col" width="1" class="formTitle">#</th>
<th scope="col" class="formTitle">Item Code</th>
<th scope="col" class="formTitle">Package Description</th>
<th scope="col" class="formTitle">Marketing Start Date</th>
<th scope="col" class="formTitle">Marketing End Date</th>
</tr>
<tr class="formTableRowAlt">
<th scope="row" class="formItem">1</th>
<td class="formItem">NDC:53041-616-58</td>
<td class="formItem">177 mL in 1 BOTTLE</td>
<td class="formItem"></td>
<td class="formItem"></td>
</tr>
</table></td></tr>
<tr><td></td></tr>
<tr><td class="normalizer"><table width="100%" cellpadding="3" cellspacing="0" class="formTableMorePetite">
<tr><td colspan="4" class="formHeadingReg"><span class="formHeadingTitle">Marketing Information</span></td></tr>
<tr>
<th scope="col" class="formTitle">Marketing Category</th>
<th scope="col" class="formTitle">Application Number or Monograph Citation</th>
<th scope="col" class="formTitle">Marketing Start Date</th>
<th scope="col" class="formTitle">Marketing End Date</th>
</tr>
<tr class="formTableRowAlt">
<td class="formItem">OTC monograph final</td>
<td class="formItem">part341</td>
<td class="formItem">12/01/2012</td>
<td class="formItem"></td>
</tr>
</table></td></tr>
</tbody></table>
<table width="100%" cellpadding="3" cellspacing="0" class="formTableMorePetite"><tr><td colspan="4" class="formHeadingReg">
<span class="formHeadingTitle">Labeler - </span>Guardian Drug Company
							(119210276)
						</td></tr></table>
</div>
<p><div class="EffectiveDate">Revised: 6/2014<div class="DocumentMetadata">
<div>
<a href="javascript:toggleMixin();">Document Id: </a>1d066711-15e9-4fc2-a241-79fcfd6d2741</div>
<div>Set id: 04c6bb6a-d2f8-4322-afba-e240e8090176</div>
<div>Version: 1</div>
<div>Effective Time: 20140606</div>
</div>
</div> <div class="DistributorName">Guardian Drug Company</div></p>
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