LORTUSS DM- dextromethorphan hydrobromide, doxylamine succinate, pseudoephedrine hydrochloride liquid 
Poly Pharmaceuticals

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.

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LORTUSS DM LIQUID

Drug Facts

<p><strong>Active ingredients<br />
<br />
(in each 5 mL teaspoonful) </strong></p>

<p></p>

<p><br />
Dextromethorphan Hydrobromide 15 mg<br />
<br />
Doxylamine Succinate 6.25 mg<br />
<br />
Pseudoephedrine Hydrochloride 30 mg<br />
&nbsp;</p>

<p></p>

Purpose

<p>Antitussive<br />
<br />
Antihistamine<br />
<br />
Decongestant<br />
&nbsp;</p>

Uses


<p>temporarily relieves these symptoms due to the common cold, hay fever allergic rhinitis) or other upper respiratory allergies:<br />
&nbsp;</p>
<ul>
<li>runny nose</li>
<li>sneezing</li>
<li>itching of nose or throat</li>
<li>itchy, watery eyes</li>
<li>cough due to minor throat and bronchial irritation</li>
<li>nasal congestion</li>
<li>reduces swelling of nasal passages<br />
&nbsp;</li>
</ul>

Warnings

Do not exceed recommended dosage.

Do not use this product


<ul>
<li>if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.&nbsp; If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.<br />
&nbsp;</li>
</ul>

Ask a doctor before use if you have


<ul>
<li>a breathing problem such as emphysema or chronic bronchitis</li>
<li>glaucoma</li>
<li>trouble urinating due to an enlarged prostate gland</li>
<li>a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema</li>
<li>a cough that occurs with too much phlegm (mucus)</li>
<li>heart disease</li>
<li>high blood pressure</li>
<li>thyroid disease</li>
<li>diabetes mellitus<br />
&nbsp;</li>
</ul>

Ask a doctor or pharmacist before use if you are

<p>taking sedatives or tranquilizers.<br />
&nbsp;</p>

When using this product

<ul>
<li>excitability may occur, especially in children</li>
<li>may cause marked drowsiness</li>
<li>avoid alcoholic drinks</li>
<li>alcohol, sedatives, and tranquilizers may increase drowsiness</li>
<li>be careful when driving a motor vehicle or operating machinery<br />
&nbsp;</li>
</ul>

Stop use and ask a doctor if

<p>taking sedatives or tranquilizers.<br />
&nbsp;</p>

If pregnant or breast-feeding,

<p>ask a health professional before use.<br />
&nbsp;</p>

Keep out of the reach of children.

<p>In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.<br />
&nbsp;</p>

Directions

Do not exceed recommended dosage.

Adults and children
12 years of age
and older:
2 teaspoonful (10 mL)
every 6 hours, not
to exceed 8 teaspoonfuls
in a 24-hour period
Children 6 to under
12 years of age:
1 teaspoonful (5 mL)
every 6 hours, not
to exceed 4 teaspoonfuls
in a 24-hour period
Children under 6
years of age:
Not recommended


Other information

<p>Store at 59° - 86°F (15° - 30°C)<br />
&nbsp;</p>

Inactive ingredients

<p>Citric Acid, Candy Apple Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol<br />
&nbsp;</p>

Questions? Comments?

<p>Serious side effects associated with use of this product may be reported to this number.&nbsp; Call 1-800-882-1041 Mon. - Fri. (8 a.m. to 5 p.m. CST).<br />
&nbsp;</p>

PRODUCT PACKAGING

label2

label

<p>The packaging below represents the labeling currently used:<br />
<br />
<br />
<br />
Principal display panel and side panel for 473 mL label:<br />
<br />
<br />
<br />
NDC 50991-598-16<br />
<br />
<br />
<br />
LORTUSS DM LIQUID<br />
<br />
<br />
<br />
Antitussive / Antihistamine / Decongestant<br />
<br />
<br />
<br />
Each 5 mL (1 teaspoonful) contains:<br />
<br />
<br />
<br />
Dextromethorphan HBr.......................15 mg<br />
<br />
Doxylamine Succinate.....................6.25 mg<br />
<br />
Pseudoephedrine HCl.........................30 mg<br />
<br />
<br />
<br />
Candy Apple Flavor<br />
<br />
<br />
<br />
SUGAR FREE / ALCOHOL FREE<br />
<br />
DYE FREE<br />
<br />
<br />
<br />
Distributed by:<br />
<br />
Poly Pharmaceuticals<br />
<br />
Mobile, AL&nbsp; 36619<br />
<br />
<br />
<br />
16 fl oz. (473 mL)<br />
<br />
<br />
<br />
Tamper evident by foil seal under cap.&nbsp; Do not use if foil seal is broken or missing.<br />
<br />
<br />
<br />
Dispense in a tight, light-resistant container with a child-resistant cap.<br />
<br />
<br />
<br />
This bottle is not to be dispensed to consumer.<br />
<br />
<br />
<br />
Manufactured by:&nbsp; Great Southern Laboratories, Houston, TX&nbsp; 77099<br />
<br />
<br />
<br />
Distributed by:&nbsp; Poly Pharmaceuticals, Mobile, AL&nbsp; 36619<br />
<br />
<br />
<br />
Iss. 11/10<br />
<br />
<br />
<br />

LORTUSS  DM
dextromethorphan hydrobromide, doxylamine succinate, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-598
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorAPPLE, COTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-598-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/201102/01/2018
2NDC:50991-598-1512 in 1 TRAY03/14/201102/01/2018
215 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/14/201102/01/2018
Labeler - Poly Pharmaceuticals (198449894)

Revised: 2/2018
Document Id: 64a83872-3f65-f025-e053-2991aa0ad36b
Set id: 784843f7-2d13-4831-a50d-d109a371966d
Version: 2
Effective Time: 20180207
 
Poly Pharmaceuticals