FDA.reportPublic FDA data

Miclara DM

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 23:48:05

Label at a glance#

ProductMiclara DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat or bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages

Dosage and administration

Do not exceed recommended dosage. Age Dose Adults and children 12 years of age and older: 1 teaspoonful (5mL) every 4 hours, not to exceed 4 teaspoonfuls (20mL) in a 24-hour period or as directed by a doctor Children 6 to under 12 years of age: ½ teaspoonful (2.5mL) every 4 hours, not to exceed 2 teaspoonfuls (10mL) 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

MICLARA LQ LIQUID

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful)

Dextromethorphan HBr       20mg

Phenylephrine HCl             10mg

Triprolidine HCl             2.5 mg

Uses

INDICATIONS & USAGE SECTION

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

  • cough due to minor throat or bronchial irritation
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

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 giving this product.

Ask a doctor before use if you have 

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • heart disease
  • high blood pressure
  • a cough that occurs with too much phlegm (mucus)
  • a persistent chronic cough such occurs with smoking, asthma, chronic bronchitis, or emphysema

 

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • new symptoms occur
  • nervousness, dizziness, or sleeplessness occur
  • Cough or nasal congestion lasts for more than 1 week, tends to recur or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

      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.

AgeDose
Adults and children 12 years of age and older:1 teaspoonful (5mL) every 4 hours, not to exceed 4 teaspoonfuls (20mL) in a 24-hour period or as directed by a doctor
Children 6 to under 12 years of age:½ teaspoonful (2.5mL) every 4 hours, not to exceed 2 teaspoonfuls (10mL) 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, 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 70868-740-16
MICLARA DM
Bubble gum flavor
16 fl oz (473 mL)

PRICIPAL DISPLAY PANEL NDC 70868-740-16 MICLARA DM Bubble gum flavor 16 fl oz (473 mL)PRICIPAL DISPLAY PANEL NDC 70868-740-16 MICLARA DM Bubble gum flavor 16 fl oz (473 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1492052dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 5 mL Oral SolutionPSN3
1492052dextromethorphan hydrobromide 4 MG/ML / phenylephrine hydrochloride 2 MG/ML / triprolidine hydrochloride 0.5 MG/ML Oral SolutionSCD3
1492052dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 5 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
70868-740-162023-07-28C16284748780-1d6a99b39-94f3-a426-e053-dadaa90af4c2Miclara DM
70868-740-162022-02-04C16284748780-1d6a99b39-94f3-a426-e053-dadaa90af4c2Miclara DM
70868-740-162022-01-28C16284748780-1d6a99b39-94f3-a426-e053-dadaa90af4c2Miclara DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70868-740-16Miclara DM473 mL in 1 BOTTLELIQUID4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70868-740MICLARA DM (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) LIQUID [KEY THERAPEUTICS]3Legacy NDC, 1 package rows20220205_c86e012b-17d0-4ffd-b815-9c07771bfaf1.zip

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
70868-74070868-740-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM CITRATEEE90ONI6FFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB

Source Document#

Source XML

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-7c79-8640-e053-2995a90a7b1ec86e012b-17d0-4ffd-b815-9c07771bfaf12022-01-26WarningsExact identifier
spl id: d67cf0cc-7c79-8640-e053-2995a90a7b1e
spl set id: c86e012b-17d0-4ffd-b815-9c07771bfaf1

Reported adverse events (FAERS/openFDA)#

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