FDA.reportPublic FDA data

Triprolidine HCl Drops

Manufacturer
Prime Labs LLC dba Quality CDMO
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-06-03 17:45:11

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Triprolidine HCl Drops

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

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, sucralose, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

Call 682-812-2222

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front LabelFront Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130371321701502GTIN-13: 0371321701502
EAN-13: 0371321701502
GTIN-12: 371321701502
UPC-A: 371321701502
GTIN storage (14 digits): 00371321701502		Triprolidine HCI Drops 1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508

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
80587-18280587-182-01

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
SUCRALOSE96K6UQ3ZD4IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
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
43f7ccb2-cca1-5727-e063-6394a90a9ac943f7cd5f-e5c5-54bf-e063-6394a90a59db2025-11-19WarningsExact identifier
spl id: 43f7ccb2-cca1-5727-e063-6394a90a9ac9
spl set id: 43f7cd5f-e5c5-54bf-e063-6394a90a59db

Reported adverse events (FAERS/openFDA)#

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