HISTEX™ Chewable Tablets

HISTEX by

Drug Labeling and Warnings

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

Drug Details [pdf]

HISTEX- triprolidine hydrochloride tablet, chewable 
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™ Chewable Tablets

Drug Facts

Active ingredient (in each chewable tablet)

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 you have

  • 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

When using this product

  • 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

  • new symptoms occur

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

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
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

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

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

Questions? Comments?

Call 1-866-633-9033.

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

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
HISTEX 
triprolidine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 28595-805
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorBLUE (speckled) Scoreno score
ShapeROUNDSize9mm
FlavorBERRYImprint Code 805
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 28595-805-6060 in 1 BOTTLE; Type 0: Not a Combination Product07/24/201712/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/24/201712/31/2019
Labeler - Allegis Pharmaceuticals, LLC (792272861)

Revised: 1/2020
Document Id: 75c2b0a7-7eab-439b-915d-39d4a2cda779
Set id: 688f9e6a-ae7d-44d0-87bf-75a447acf999
Version: 2
Effective Time: 20200123
 
Allegis Pharmaceuticals, LLC