FDA Label for Lortuss Lq

View Indications, Usage & Precautions

Lortuss Lq Product Label

The following document was submitted to the FDA by the labeler of this product Key Therapeutics. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 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 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, Propylparaben, Propylene Glycol, Purified Water, Sucralose.


Questions? Comments?



Serious side effects associated with use of this product May be reported to this number. Call 1-888-981-8337

Mon - Fri (8 a.m. to 5 p.m. CST)      


Principal Display Panel



NDC 70868-750-16 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)

Distributed by:

      Key Therapeutics, LLC

      Flowood, MS 39232

      Iss. 03/20


* Please review the disclaimer below.