LORTUSS DM- dextromethorphan hydrobromide, doxylamine succinate, pseudoephedrine hydrochloride liquid

LORTUSS by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
(in each 5 mL teaspoonful)
Dextromethorphan Hydrobromide 15 mg
Doxylamine Succinate 6.25 mg
Pseudoephedrine Hydrochloride 30 mg

Purpose

Antitussive
Antihistamine
Decongestant

Uses

temporarily 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 are taking 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 children12 years of age and older: 2 teaspoonful (10 mL) every ; 6 hours, not to exceed ; 8 teaspoonfuls in a 24-hour ; period or as directed by a doctor
• Children 6 to under12 years of age: 1 teaspoonful (5 mL) every ; 6 hours, not to exceed ; 4 teaspoonfuls in a 24-hour; period or as directed by a doctor
• Children under 6 years of age: Not recommended

Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

Apple Flavor, Citric Acid, Cotton Candy Flavor, Glycerin, Monoammonium glycyrrhizinate, Methylparaben, Potassium Citrate, Potassium Sorbate, Propylparaben, Propylene Glycol, Purified Water, 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: 69036-120-16
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

16 fl oz. (473 mL)

INGREDIENTS AND APPEARANCE

LORTUSS  DM
dextromethorphan hydrobromide, doxylamine succinate, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69036-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 5 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 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)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69036-120-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/14/2014

Labeler - Sallus Laboratories, LLC (079418254)