LORTUSS EX- codeine phosphate, guaifenesin and pseudoephedrine hydrochloride solution
Poly Pharmaceuticals, Inc.

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 EX

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg
Guaifenesin 100 mg
Pseudoephedrine Hydrochloride 22.5 mg

Purpose

Cough Suppressant
Expectorant
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
codeine phosphate, guaifenesin, pseudoephedrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:50991-515
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CODEINE PHOSPHATE (CODEINE ANHYDROUS)	CODEINE PHOSPHATE	10 mg in 5 mL
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	100 mg in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE)	PSEUDOEPHEDRINE HYDROCHLORIDE	22.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM CITRATE
SACCHARIN SODIUM
SORBITOL

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:50991-515-15	6 in 1 TRAY
1		15 mL in 1 BOTTLE; Combination Product Type = C112160
2	NDC:50991-515-16	473 mL in 1 BOTTLE; Combination Product Type = C112160

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	11/20/2009	04/10/2014

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 7/2014

Document Id: 20aea83b-f036-41c4-868c-03342a20f33e

Set id: 243f746f-34fd-42e6-8c2a-274e4e4909c1

Version: 7

Effective Time: 20140701

Poly Pharmaceuticals, Inc.