FDA.reportPublic FDA data

Miclara LQ

Manufacturer
Key Therapeutics | TG United
Effective date
2022-01-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:03

Label at a glance#

ProductMiclara LQ
Active ingredientTRIPROLIDINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and older: Children 6 to under 12 years of age: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls (40mL) in 24-hour period or as directed by a doctor. 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls (20mL) in a 24-hour period or as directed by a doctor. Children under 6 years of age:       Consult a do...

Storage and handling

Store at 59° - 86°F (15° - 30°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Miclara LQ- triprolidine  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.

----------

MICLARA LQ LIQUID

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful) Triprolidine HCl 1.25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

  • runny nose
  • sneezing
  • itching of the nose or throat itchy,
  • watery eyes

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

 

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • may cause excitability especially in children
  • may cause 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

  • new symptoms occur

      If pregnant or breast-feeding, 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:

Children 6 to under 12 years of age:

2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed

8 teaspoonfuls (40mL) in 24-hour

period or as directed by a doctor.

1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls (20mL) 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

Bubble gum flavor, citric acid, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, 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 70868-730-16 Miclara LQ

Antihistamine

Each 5 mL (1 teaspoonful) contains: Triprolidine HCl 1.25 mg………Antihistamine

Bubble Gum Flavor

Dye Free - Sugar Free - Alcohol Free

16 fl oz. (473 mL)

Distributed by:

      Key Therapeutics, LLC

      Flowood, MS 39232

      Iss. 03/20

PRINCIPAL DISPLAY PANEL NDC 70868-730-16 Miclara LQ Antihistamine Each 5 mL (1 teaspoonful) contains: Triprolidine HCl 1.25 mg………Antihistamine Bubble Gum Flavor Dye Free - Sugar...PRINCIPAL DISPLAY PANEL NDC 70868-730-16 Miclara LQ Antihistamine Each 5 mL (1 teaspoonful) contains: Triprolidine HCl 1.25 mg………Antihistamine Bubble Gum Flavor Dye Free - Sugar...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099684triprolidine hydrochloride 1.25 MG in 5 mL Oral SolutionPSN3
1099684triprolidine hydrochloride 0.25 MG/ML Oral SolutionSCD3
1099684triprolidine hydrochloride 1.25 MG per 5 ML Oral SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70868-730-162023-07-28C16284748780-1d6a99b39-d9e9-a426-e053-dadaa90af4c2Miclara LQ
70868-730-162022-02-04C16284748780-1d6a99b39-d9e9-a426-e053-dadaa90af4c2Miclara LQ
70868-730-162022-01-28C16284748780-1d6a99b39-d9e9-a426-e053-dadaa90af4c2Miclara LQ

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70868-730-16Miclara LQ473 mL in 1 BOTTLELIQUID4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70868-730MICLARA LQ (TRIPROLIDINE HYDROCHLORIDE) LIQUID [KEY THERAPEUTICS]3Legacy NDC, 1 package rows20220205_b1e0f143-e192-4bab-9163-ae21c765b765.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70868-730-16ML - Milliliter70868-730a3ea0253-cb43-4701-af8a-09b6e1cbbc7a12020-07-13

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70868-73070868-730-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLPARABENA2I8C7HI9TIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
POTASSIUM CITRATEEE90ONI6FFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB

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
d67cfbdf-9636-4ba6-e053-2a95a90aacbbb1e0f143-e192-4bab-9163-ae21c765b7652022-01-26WarningsExact identifier
spl id: d67cfbdf-9636-4ba6-e053-2a95a90aacbb
spl set id: b1e0f143-e192-4bab-9163-ae21c765b765

Reported adverse events (FAERS/openFDA)#

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