FDA.reportPublic FDA data

Triprolidine HCl Drops

Manufacturer
Brandywine Pharmaceuticals, LLC
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:06:56

Label at a glance#

ProductTriprolidine HCl Drops
Active ingredientTRIPROLIDINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

■ use only with enclosed dropper   ■ mL= milliliter ■ do not use dropper for any other drug product children 6 to under 12 years: 2 mL every 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor. children under 6: ask a doctor. ■ use only with enclosed dropper   ■ mL= milliliter ■ do not use dropper for any other drug product children 6 to under 12 years: 2 mL every 6 hours, not to exceed 4 doses ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Triprolidine HCl Drops

NDC 71321-701-50

Active ingredients (in each 2 mL)

OTC - ACTIVE INGREDIENT SECTION

Triprolidine HCI 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 ■ itching of the nose or throat

■ sneezing ■ itchy, watery eyes

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

■ trouble urinating due to an enlarged prostate

Ask a doctor before use if the child is

SPL UNCLASSIFIED SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ excitability may occur, especially in children

■ marked drowsiness may occur

■ sedatives and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ new symptoms occur

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.

Directions

DOSAGE & ADMINISTRATION SECTION

■ use only with enclosed dropper   ■ mL= milliliter

■ do not use dropper for any other drug product

children 6 to under 12 years: 2 mL every 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor.

children under 6: ask a doctor.

Directions

RECENT MAJOR CHANGES SECTION

■ use only with enclosed dropper   ■ mL= milliliter

■ do not use dropper for any other drug product

children 6 to under 12 years: 2 mL every 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor.

children under 6: ask a doctor.

Other information

OTHER SAFETY INFORMATION

■ read all product information before using

■ this packaging is child-resistant.

■ store at room temperature 20-30°C (68-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

Call 610-314-7943 9 a.m. - 5 p.m. EST.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71321-701-50



Triprolidine HCl Drops



1.69 fl oz (50 mL)

LabelLabelCartonCartonPeel_BackPeel_Back

DailyMed Product Concepts#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71321-701TRIPROLIDINE HCL DROPS (TRIPROLIDINE HYDROCHLORIDE) LIQUID [BRANDYWINE PHARMACEUTICALS, LLC]3Unmatched20240110_f66a4235-d1a5-d2fa-e053-2a95a90a67f9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71321-701-50ML - Milliliter71321-70107239ffb-ab02-4e66-a17d-d2eb0deff92412023-04-07

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71321-70171321-701-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
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
47d40763-f19b-a5df-e063-6394a90af7bdf66a4235-d1a5-d2fa-e053-2a95a90a67f92026-01-07WarningsExact identifier
spl set id: f66a4235-d1a5-d2fa-e053-2a95a90a67f9

Reported adverse events (FAERS/openFDA)#

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