Active Ingredients
(in each 5 mL teaspoonful) Doxylamine Succinate 6.25 mg Pseudoephedrine Hydrochloride 30 mg
Lortuss Lq
FDA Label NDC 70868-750
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Key Therapeutics for the product Lortuss Lq (NDC 70868-750). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use this product, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Product Packaging Ndc 70868-750-16 Lortuss Lqantihistamine / Decongestanteach 5 mL (1 Teaspoonful) Contains: Doxylamine Succinate 6.25 mgpseudoephedrine HCl 30 mggrape Flavordye Free (Sugar Free)
* Please review the disclaimer below.
