HISTEX PD Drops description, usages, side effects, indications, overdosage, supplying and lots more!

HISTEX PD Drops

Allegis Pharmaceuticals, LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
HISTEX™ PD Drops

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

AGE DOSE
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 age ⅔ 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 age ⅓ 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)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

HISTEX PD Drops

TRIPROLIDINE HYDROCHLORIDE SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:28595-801
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
triprolidine hydrochloride TRIPROLIDINE 0.938 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 NDC:28595-801-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-03-06


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Be sure to consult your doctor before taking any medication!
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