LORTUSS EX- codeine phosphate, guaifenesin, pseudoephedrine hydrochloride liquid

LORTUSS by

Drug Labeling and Warnings

LORTUSS by is a Otc medication manufactured, distributed, or labeled by Sallus Laboratories, LLC, TG United Liquid, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg
Guaifenesin 100 mg
Pseudoephedrine Hydrochloride 30 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, chronic bronchitis 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

When using this product

May cause or aggravate constipation

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 (10 mL) every ; 4 hours, not to exceed ; 8 teaspoonfuls in a 24-hour ; period or as directed by a doctor
• Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every; 4 hours, not to exceed ; 4 teaspoonfuls in a 24-hour ; period or as directed by a doctor
• Children under 6 years of age: Consult a doctor

Other information

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

Inactive ingredients

Apple Cinnamon Flavor, Citric Acid, Glycerin, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number. Call 1-205-314-4780
Mon-Fri (8 a.m. to 5 p.m. CST)                              Iss. 06/14     

PRINCIPAL DISPLAY PANEL

Principal Display Panel
NDC: 69036-130-16
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................ 30 mg
Apple Cinnamon Flavor
Alcohol Free / Sugar Free
Dye Free
CV
16 fl. oz. (473 mL)

INGREDIENTS AND APPEARANCE

LORTUSS  EX
codeine phosphate, guaifenesin, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69036-130
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	APPLE (Apple Cinnamon Flavor) , CINNAMON (Apple Cinnamon Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69036-130-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/01/2014

Labeler - Sallus Laboratories, LLC (079418254)

Establishment
Name	Address	ID/FEI	Business Operations
TG United Liquid, Inc.		830980947	MANUFACTURE(69036-130)