HISTEX PDX Drops by Allegis Pharmaceuticals, LLC HISTEX™ PDX Drops

HISTEX PDX Drops by

Drug Labeling and Warnings

HISTEX PDX Drops by is a Otc medication manufactured, distributed, or labeled by Allegis Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HISTEX PDX DROPS- triprolidine hydrochloride syrup 
Allegis Pharmaceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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HISTEX™ PDX Drops

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:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

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.

  • For dosing, use only the enclosed dropper and not with any other drug product.
  • Professional Labeling: Take under the guidance of Health Professionals.
AGEDOSE
Children 4 to under 6 years of age:¾ dropperful (0.75 mL) every 4 to 6 hours, not to exceed 4 doses (3.0 mL) in 24 hours or as directed by a Doctor.
Children 2 to under 4 years of age:½ dropperful (0.5 mL) every 4 to 6 hours, not to exceed 4 doses (2.0 mL) in 24 hours or as directed by a Doctor.
Infants 4 months to under 2 years of age:¼ dropperful (0.25 mL) every 4 to 6 hours, not to exceed 4 doses (1.0 mL) in 24 hours or as directed by a Doctor.

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, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose.

Questions? Comments?

Call 1-866-633-9033.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

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)

Principal Display Panel - 30 mL Bottle Carton
HISTEX PDX DROPS 
triprolidine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 28595-808
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 28595-808-301 in 1 CARTON06/22/201712/31/2019
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 FINALpart34106/22/201712/31/2019
Labeler - Allegis Pharmaceuticals, LLC (792272861)

Revised: 1/2020