LORTUSS DM

Dosage form: liquid
Ingredients: Dextromethorphan Hydrobromide 15mg in 5mL, Doxylamine Succinate 6.25mg in 5mL
Labeler: Poly Pharmaceuticals
NDC Code: 50991-598

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.

LORTUSS DM LIQUID

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

Dextromethorphan Hydrobromide 15 mg
Doxylamine Succinate 6.25 mg
Pseudoephedrine Hydrochloride 30 mg

PurposeAntitussive
Antihistamine
Decongestant

Usestemporarily relieves these symptoms due to the common cold, hay fever allergic rhinitis) or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

Warnings Do not exceed recommended dosage.

Do not use this product
  • 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.  If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

When using this product
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  These could be signs of a serious condition.
  • new symptoms occur

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

Keep out of the reach of children.In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

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 informationStore at 59° - 86°F (15° - 30°C)

Inactive ingredientsCitric Acid, Candy Apple Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol

Questions? Comments?Serious side effects associated with use of this product may be reported to this number.  Call 1-800-882-1041 Mon. - Fri. (8 a.m. to 5 p.m. CST).

PRODUCT PACKAGINGThe packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 50991-598-16

LORTUSS DM LIQUID

Antitussive / Antihistamine / Decongestant

Each 5 mL (1 teaspoonful) contains:

Dextromethorphan HBr.......................15 mg
Doxylamine Succinate.....................6.25 mg
Pseudoephedrine HCl.........................30 mg

Candy Apple Flavor

SUGAR FREE / ALCOHOL FREE
DYE FREE

Distributed by:
Poly Pharmaceuticals
Mobile, AL  36619

16 fl oz. (473 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant cap.

This bottle is not to be dispensed to consumer.

Manufactured by:  Great Southern Laboratories, Houston, TX  77099

Distributed by:  Poly Pharmaceuticals, Mobile, AL  36619

Iss. 11/10





LORTUSS  DM
dextromethorphan hydrobromide, doxylamine succinate, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-598
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide15 mg  in 5 mL
Doxylamine Succinate (Doxylamine) Doxylamine Succinate6.25 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorAPPLE, COTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50991-598-16473 mL in 1 BOTTLE
2NDC:50991-598-1512 BOTTLE (BOTTLE) in 1 TRAY
215 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/14/2011
Labeler - Poly Pharmaceuticals (198449894)

Revised: 03/2011
 
Poly Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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