FDA.reportPublic FDA data

HISTEX PDX Drops

Manufacturer
Allegis Pharmaceuticals, LLC
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:15:21

Label at a glance#

ProductHISTEX PDX Drops
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. use only the enclosed dropper. do not use enclosed dropper for any other drug products. AGE DOSE Adutls & Children 12 years of age or older: 2 mL (2.5 mg) every 4 to 6 hours, not to exceed 8 mL (10 mg) in 24 hours or as directed by a doctor. Children 6 to under12 years of age: 1 mL (1.25 mg) every 4 to 6 hours, not to exceed 4 mL (5 mg) in 24 hours or as directed by a doctor. Chil...

Storage and handling

Store at 15°-30° C (59°-86° F). Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 1 mL dropperful)

OTC - ACTIVE INGREDIENT SECTION

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

OTC - DO NOT USE SECTION

Do not exceed recommended dosage.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if the child is taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • sedatives and tranquilizers may increase the drowsiness effect

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • new symptoms occur

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

  • use only the enclosed dropper.
  • do not use enclosed dropper for any other drug products.
AGEDOSE
Adutls & Children 12 years of age or older:2 mL (2.5 mg) every 4 to 6 hours, not to exceed 8 mL (10 mg) in 24 hours or as directed by a doctor.
Children 6 to under12 years of age:1 mL (1.25 mg) every 4 to 6 hours, not to exceed 4 mL (5 mg) in 24 hours or as directed by a doctor.
Children under 6 years of age: Consult a docotor.

Other Information

STORAGE AND HANDLING SECTION

Store at 15°-30° C (59°-86° F).

Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

bubble gum flavor, citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

Questions? Comments?

OTC - QUESTIONS SECTION

Call 1-866-633-9033.

Recent Major Changes

RECENT MAJOR CHANGES SECTION

The Direction section has been updated with new dosage information.

Inactive ingredients section has been updated to reflect the change in two ainactive ingredients

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 28595-808-30

HISTEX™ PDX

Drops

Antihistamine

Each dropperful (1 mL)

contains:

Triprolidine HCl

1.25 mg

Sugar-Free • Dye Free

Alcohol Free

Bubble Gum Flavor

1 fl oz (30 mL) Bottle

CartonCarton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-808HISTEX PDX DROPS (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]4Legacy NDC20240110_55a1a577-93af-4f4e-8858-430f4e2f6e56.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-808-30ML - Milliliter28595-808261a4b6c-d2d3-4128-b44a-410fb0a4ac7212017-08-11

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
28595-80828595-808-30

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
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
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
4af6bc59-9a4f-8a45-e063-6294a90ada7f55a1a577-93af-4f4e-8858-430f4e2f6e562026-02-16WarningsExact identifier
spl set id: 55a1a577-93af-4f4e-8858-430f4e2f6e56

Reported adverse events (FAERS/openFDA)#

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