FDA.reportPublic FDA data

LORTUSS LQ

Manufacturer
Key Therapeutics | TG United
Effective date
2022-01-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:00

Label at a glance#

ProductLORTUSS LQ
Active ingredientDOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure11 sections

Indications and 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

Dosage and administration

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

Storage and handling

Store at 59° - 86°F (15° - 30°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

LORTUSS LQ- doxylamine succinate, pseudoephedrine hydrochloride liquid

Key Therapeutics

Disclaimer: Most OTC drugs are not reviewed and approved by FDA; however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

LORTUSS LQ LIQUID

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful) Doxylamine Succinate 6.25 mg Pseudoephedrine Hydrochloride 30 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine Decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

now taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose seek professional help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerin, Grape Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Potassium Sorbate, Propylparaben, Propylene Glycol, Purified Water, Sucralose.

Questions? Comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.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 LQ Antihistamine / Decongestant Each 5 mL (1 teaspoonful) contains: Doxylamine Succinate 6.25 mg Pseudoephedrine HCl 30 mg Grape Flavo...Product Packaging NDC 70868-750-16 LORTUSS LQ Antihistamine / Decongestant Each 5 mL (1 teaspoonful) contains: Doxylamine Succinate 6.25 mg Pseudoephedrine HCl 30 mg Grape Flavo...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094355doxylamine succinate 6.25 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN2
1094355doxylamine succinate 1.25 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD2
1094355doxylamine succinate 6.25 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70868-750-162023-07-28C16284748780-1d6a99b39-3d85-a426-e053-dadaa90af4c2Lortuss LQ
70868-750-162022-02-04C16284748780-1d6a99b39-3d85-a426-e053-dadaa90af4c2Lortuss LQ
70868-750-162022-01-28C16284748780-1d6a99b39-3d85-a426-e053-dadaa90af4c2Lortuss LQ

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70868-750-16LORTUSS LQ473 mL in 1 BOTTLELIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70868-750LORTUSS LQ (DOXYLAMINE SUCCINATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KEY THERAPEUTICS]2Legacy NDC, 1 package rows20220205_75eb63ff-88fd-450d-82d7-c91165929568.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70868-750-16ML - Milliliter70868-7503c462e62-cdeb-4680-99af-82a94d00e35012020-08-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70868-75070868-750-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
POTASSIUM CITRATEEE90ONI6FFIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d67cf0cc-7c66-8640-e053-2995a90a7b1e75eb63ff-88fd-450d-82d7-c911659295682022-01-26WarningsExact identifier
spl id: d67cf0cc-7c66-8640-e053-2995a90a7b1e
spl set id: 75eb63ff-88fd-450d-82d7-c91165929568

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.