HISTEX™ Chewable Tablets

Manufacturer
Allegis Pharmaceuticals, LLC
Effective date
2017-07-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:14:38

Label at a glance#

ProductHISTEX
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 sneezing itching of the nose or throat itchy, watery eyes

Dosage and administration

Do not exceed recommended dosage. AGE DOSE Adults and Children 12 years of age and older 2 chewable tablets every 4 to 6 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years of age 1 chewable tablet every 4 to 6 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor. Children under 6 years of age Consult a doctor

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 chewable tablet)

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

Do not exceed recommended dosage.

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

Ask a doctor before use if you are taking sedatives or tranquilizers

OTC - ASK DOCTOR/PHARMACIST SECTION

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • new symptoms occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

SPL UNCLASSIFIED SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

AGEDOSE
Adults and Children 12 years of age and older2 chewable tablets every 4 to 6 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age1 chewable tablet every 4 to 6 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor.
Children under 6 years of ageConsult a doctor

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

Berry Blend, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sucralose, xylitol

Questions? Comments?

OTC - QUESTIONS SECTION

Call 1-866-633-9033.

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 28595-805-60

Antihistamine
HISTEX™

Chewable Tablets

Each chewable tablet contains:
Triprolidine HCl
1.25 mg

Sugar-Free • Dye Free

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

Berry Flavor

60 Tablets

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-805-60EA - Each28595-805d99a2103-8bd1-49ce-8b45-8e63fccfe98b12017-08-11

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
28595-80528595-805-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
145e5e82-705c-499d-8bf6-863858e2d8f0688f9e6a-ae7d-44d0-87bf-75a447acf9992017-07-26WarningsExact identifier
spl id: 145e5e82-705c-499d-8bf6-863858e2d8f0
spl set id: 688f9e6a-ae7d-44d0-87bf-75a447acf999

Reported adverse events (FAERS/openFDA)#

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