LORTUSS LQ- 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 LQ LIQUID

Drug Facts

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

<p></p>

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

<p></p>

Purpose

<p>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>itchy, water eyes</li>
<li>sneezing</li>
<li>itching of the nose or throat</li>
<li>cough due to minor throat and bronchial irritation</li>
<li>nasal congestion</li>
<li>reduces swelling of nasal passage<br />
&nbsp;</li>
</ul>

Warnings

Do not exceed recommended dosage.

Do not use this product


<ul>
<li>do not use this with any product containing diphenhydramine, even one used on skil</li>
<li>if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depresion, 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 especially in children</li>
<li>glaucoma</li>
<li>trouble urinating due to an enlarged prostate gland</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>now taking sedatives or tranquilizers.<br />
&nbsp;</p>

When using this product


<ul>
<li>may cause excitability 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


<ul>
<li>nervousness, dizziness, or sleeplessness occur</li>
<li>cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.&nbsp; These could be signs of serious condition</li>
<li>new symptoms occur<br />
&nbsp;</li>
</ul>

If pregnant or breast-feeding, ask a health professional before use.

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 teaspoonfuls (10 mL)
every 6 hours, not to
exceed 8 teaspoonfuls
in 24 hours.
Children 6 to under
12 years of age:


1 teaspoonful (5 mL)
every 6 hours, not to
exceed 4 teaspoonfuls
in 24 hours.
Children under 6
years of age:
Use not recommended.

Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

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

label2label

<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 />
&nbsp;</p>

<p><strong>NDC 50991-597-16<br />
<br />
<br />
<br />
LORTUSS LQ LIQUID </strong></p>

<p></p>

<p></p>

<p></p>

<p></p>

<p><strong>Antihistamine / Decongestant</strong></p>

<p>&nbsp;
<p>&nbsp;
<p>&nbsp;
<p><br />
Each 5 mL (1 teaspoonful) contains:<br />
<br />
Doxylamine Succinate.....................6.25 mg<br />
<br />
Pseudoephedrine HCl.........................30 mg</p>
</p>
</p>
</p>

<p></p>

<p></p>

<p></p>

<p></p>

<p></p>

<p></p>

<p></p>

<p></p>

<p><strong>Grape Flavor<br />
<br />
<br />
<br />
Dye Free - Sugar Free - Alcohol 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) </strong><br />
&nbsp;</p>

<p>&nbsp;
<p><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 NOT TO BE DISPENSED TO CONSUMER.</p>
</p>

<p></p>

<p></p>

<p></p>

<p></p>

<p></p>

<p></p>

<p></p>

<p></p>

<p><strong>Manufactured by:</strong></p>

<p>&nbsp; Great Southern Laboratories, Houston, TX&nbsp; 77099</p>

<p></p>

<p></p>

<p></p>

<p></p>

<p></p>

<p></p>

<p></p>

<p></p>

<p><strong>Distributed for:</strong></p>

<p>&nbsp; Poly Pharmaceuticals, Mobile, AL&nbsp; 36619<br />
<br />
<br />
<br />
Iss. 11/10<br />
<br />

LORTUSS  LQ
doxylamine succinate, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-597
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 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
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-597-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/22/201102/01/2018
2NDC:50991-597-1512 in 1 TRAY02/22/201102/01/2018
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 finalpart34102/22/201102/01/2018
Labeler - Poly Pharmaceuticals (198449894)

Revised: 2/2018
Document Id: 64a827ee-facd-684a-e053-2a91aa0ad447
Set id: fe74017b-3387-4e72-9e2d-9eb46465c3df
Version: 2
Effective Time: 20180207
 
Poly Pharmaceuticals