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HISTEX PD Drops

Dosage form: syrup
Ingredients: TRIPROLIDINE HYDROCHLORIDE 0.938mg in 1mL
Labeler: Allegis Pharmaceuticals, LLC
NDC Code: 28595-801

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.

HISTEX™ PD Drops

Drug Facts

Active ingredients (in each 1 mL dropperful)

Triprolidine HCl 0.938 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.

AGEDOSE
Childen 4 to under 6 years of age:1 dropperful (1.0 mL) every 4 to 6 hours, not to exceed 4 doses (4.0 mL) in 24 hours
Children 2 to under 4 years of age⅔ dropperful (0.67 mL) every 4 to 6 hours, not to exceed 4 doses (2.67 mL) in 24 hours
Infants 4 months to under 2 years of age⅓ dropperful (0.33 mL) every 4 to 6 hours, not to exceed 4 doses (1.33 mL) in 24 hours

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.

Dispense in a tight, light-resistant container with a child-resistant cap.

Inactive ingredients

Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Bubble Gum Flavor.

Questions? Comments?

Call 1-866-633-9033.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

NDC 28595-801-30

Antihistamine
Histex™ PD
Drops

Each dropperful (1 mL)
contains:

Triprolidine HCl 0.938 mg

Sugar-Free • Dye Free
Alcohol Free

Bubble Gum Flavor

1 fl oz (30 mL)

HISTEX PD DROPS 
triprolidine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28595-801
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIPROLIDINE HYDROCHLORIDE (TRIPROLIDINE) TRIPROLIDINE HYDROCHLORIDE0.938 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM CITRATE 
SACCHARIN SODIUM 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:28595-801-301 BOTTLE in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/06/2014
Labeler - Allegis Pharmaceuticals, LLC (792272861)

Revised: 03/2014
 
Allegis Pharmaceuticals, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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