LORTUSS LQ- doxylamine succinate, pseudoephedrine hydrochloride liquid

LORTUSS LQ by

Drug Labeling and Warnings

LORTUSS LQ 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)
Doxylamine Succinate 6.25 mg
Pseudoephedrine Hydrochloride 30 mg

Purpose

Antihistamine
Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• runny nose
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• reduces swelling of nasal passage

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 especially in children
• glaucoma
• trouble urinating due to an enlarged prostate gland
• heart disease
• high blood pressure
• thyroid disease
• diabetes mellitus

Ask a doctor or pharmacist before use if you are

now taking sedatives or tranquilizers.

When using this product

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

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or are accompanies by fever
• new symptom 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 teaspoonfuls (10 mL) every ; 6 hours, not to exceed ; 8 teaspoonfuls in 24-hour ; period or as directed by a doctor.
• 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 or as directed by a doctor.
• Children under 6 years of age: Consult a doctor

Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

Citric Acid, Glycerin, Grape Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Potassium Sorbate, Propylpraben, 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. 08/14

Product Packaging

NDC: 69036-110-16

LORTUSS LQ

Antihistamine / Decongestant

Each 5 mL (1 teaspoonful) contains:
Doxylamine Succinate.....................6.25 mg
Pseudoephedrine HCl.........................30 mg

Grape Flavor

Dye Free - Sugar Free - Alcohol Free

16 fl oz. (473 mL)

INGREDIENTS AND APPEARANCE

LORTUSS LQ 
doxylamine succinate, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69036-110
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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)
METHYLPARABEN (UNII: A2I8C7HI9T)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69036-110-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/01/2014

Labeler - Sallus Laboratories, LLC (079418254)

Establishment
Name	Address	ID/FEI	Business Operations
TG United Liquid, Inc.		830980947	MANUFACTURE(69036-110)