Your browser does not support JavaScript! LORTUSS EX (CODEINE PHOSPHATE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [POLY PHARMACEUTICALS, INC.]
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LORTUSS EX (codeine phosphate, guaifenesin, pseudoephedrine hydrochloride) liquid
[Poly Pharmaceuticals, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL CV OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredients                                    Purpose
(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg........................ Cough Suppressant
Guaifenesin 100 mg............................................ Expectorant
Pseudoephedrine Hydrochloride 22.5 mg.... Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • 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 cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

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 over:           
2 teaspoonfuls every 6 to 8 hours, not to exceed 8 teaspoonfuls in a 24 hour period
Children 6 to under 12 years of age:
1 teaspoonful every 6 to 8 hours, not to exceed 4 teaspoonfuls in a 24 hour period
Children under 6 years of age:
Consult a doctor

Other information

Store at 59o-86oF (15o-30oC)

Inactive ingredients

citric acid, cotton candy flavor, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, and 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 PACKAGING:

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 473 mL Label:

NDC 50991-515-16

LORTUSS EX

Antitussive / Expectorant / Decongestant

Each 5 mL (1 teaspoonful) contains:
Codeine Phosphate*............. 10 mg
*(WARNING: May be habit forming)
Guaifenesin....................... 100 mg
Pseudoephedrine HCl........ 22.5 mg

Cotton Candy Flavor
Alcohol Free / Gluten Free
Sugar Free / Dye Free

CV

Rx Only

Distributed by:

Poly Pharmaceuticals
Mobile, AL 36619

16 fl oz. (473 mL)


Side Panel:


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 for:
Poly Pharmaceuticals, Mobile, AL 36619

Iss. 10/09



Principal Display Panel and Side Panel for 15 mL Label:

NDC 50991-515-15


LORTUSS EX


Antitussive / Expectorant / Decongestant

Each 5 mL (1 teaspoonful) contains:
Codeine Phosphate*................... 10 mg
*(WARNING: May be habit forming)
Guaifenesin.............................. 100 mg
Pseudoephedrine HCl................ 22.5 mg

Cotton Candy Flavor

Alcohol Free / Gluten Free
Sugar Free / Dye Free
CV
Rx Only
Professional Sample: Not For Sale
1/2 fl oz (15 mL)

Side Panel:


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

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

Manufactured by:

Great Southern Laboratories
Houston, TX 77099

Distributed For:

Poly Pharmaceuticals
Mobile, AL 36619

Iss. 11/09

Lortuss EX Packaging

Lortuss EX Packaging

Lortuss EX Packaging

Lortuss EX Packaging

LORTUSS  EX
codeine phosphate, guaifenesin, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50991-515
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (Codeine) Codeine Phosphate10 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride22.5 mg  in 5 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-515-16473 mL in 1 BOTTLE
2NDC:50991-515-1515 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/20/2009
Labeler - Poly Pharmaceuticals, Inc. (198449894)
Registrant - Great Southern Laboratories (056139553)
Establishment
NameAddressID/FEIBusiness Operations
Great Southern Laboratories056139553manufacture

Revised: 12/2009
 
Poly Pharmaceuticals, Inc.

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