HISTEX PD DROPS NEW FORMULATION- triprolidine hydrochloride syrup 
Allegis Pharmaceuticals, LLC

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HISTEX™ PD New Formulation

Drug Facts

Active ingredient (in each 1 mL dropperful)

Triprolidine HCl 1.25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if the child has

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

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

When using this product

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

Stop use and ask a doctor if

  • new symptoms occur

Keep out of the reach of children.

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

Directions

Do not exceed recommended dosage.

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

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

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

Questions? Comments?

Call 1-866-633-9033.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

NDC 28595-809-30

HISTEX™ PD New Formulation

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

Label

HISTEX PD DROPS NEW FORMULATION 
triprolidine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28595-809
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:28595-809-301 in 1 CARTON12/13/2023
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/13/2023
Labeler - Allegis Pharmaceuticals, LLC (792272861)

Revised: 12/2023
Document Id: 0d08439b-3e83-1798-e063-6394a90a1f52
Set id: 0c693f15-5d76-3dbf-e063-6294a90af9ac
Version: 2
Effective Time: 20231221
 
Allegis Pharmaceuticals, LLC