FDA.reportPublic FDA data

Triprolidine HCl Drops

Manufacturer
Creekwood Pharmaceutical Inc. | Woodfield Pharmaceutical, LLC
Effective date
2021-11-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:40

Label at a glance#

ProductTriprolidine HCl Drops
Active ingredientTRIPROLIDINE HYDROCHLORIDE
Label structure8 sections

Dosage and administration

Do Not exceed recommended dosage. Use only with enclosed dropper. Do not use with any other device. Adults and Children 12 years of age and over 2.67 mL every 4 hours to 6 hours,not to exceed 4 doses in 24 hours Children 6 years to under 12 years of age: 1.33mL every 4 to 6 hours, not to exceed 4 doses in 24 hours 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#

Other information

STORAGE AND HANDLING SECTION

Store at 59° - 86°F (15° - 30°C)

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • diffculty in urination due to the enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Do not use this product

OTC - DO NOT USE SECTION

  • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Uses

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

  • Nasal Congestion
  • reduces swelling of nasal passages
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy,watery eyes

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 1 mL dropperful)


Triprolidine Hydrochloride 0.938mg

OTC - PURPOSE SECTION

Purpose

Anitihistamine

Directions

DOSAGE & ADMINISTRATION SECTION

Do Not exceed recommended dosage.

Use only with enclosed dropper. Do not use with any other device.

Adults and Children 12 years of age and over


2.67 mL every 4 hours to 6 hours,not to exceed 4 doses in 24
hours
Children 6 years to under 12 years of age:1.33mL every 4 to 6 hours, not to exceed 4 doses in 24 hours
Children under 6 years of age:
Consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose.

Questions Comments

OTC - QUESTIONS SECTION

Seek medical assistance immediately for serious side effects associated with the use of this product. Serious side effects may be reported to this number: 866-991-9870 ( mon-Fri 8 a.m to 5 p.m EST)

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The packaging below represents the labeling currently used.



Principal display panel and side panel for 30 mL label:



NDC 15310-112-42

Triprolidine HCl Drops


Alllergic Rhintis, Respiratory Allergies & Nasal Decongestant

Common Cold





Alcohol-Free · Dye Free · Sugar Free · · Cotton Candy Flavor



Each Dropperful (1 mL) contains:

Triprolidine HCl, USP..........................0.938 mg





Net Wt. 1 FL OZ (30 mL)



Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.


Manufactured for:

Creekwood Pharmaceutical

951 Clint Moore Road,

Suite A

Boca Taton, FL 33487

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1491649triprolidine HCl 0.938 MG in 1 mL Oral SolutionPSN2
1491649triprolidine hydrochloride 0.938 MG/ML Oral SolutionSCD2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15310-112-422022-07-29C16284748780-1e4f33bdf-9e15-d8a0-e053-dadaa90a6e4eTriprolidine HCL Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15310-112-42Triprolidine HCl Drops1 in 1 BOXLIQUID12
15310-112-42Triprolidine HCl Drops30 mL in 1 BOTTLELIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15310-112TRIPROLIDINE HCL DROPS LIQUID [CREEKWOOD PHARMACEUTICAL INC.]2Legacy NDC, 2 package rows20211103_990c6ee8-69e1-6f35-e053-2a95a90a0601.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15310-112-42ML - Milliliter15310-112cd5ec3d5-afa1-4610-9098-b56aed0de3e712020-02-13

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15310-11215310-112-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
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
cfd44096-36a6-624a-e053-2995a90af1fa990c6ee8-69e1-6f35-e053-2a95a90a06012021-11-02WarningsExact identifier
spl id: cfd44096-36a6-624a-e053-2995a90af1fa
spl set id: 990c6ee8-69e1-6f35-e053-2a95a90a0601

Reported adverse events (FAERS/openFDA)#

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