Histex™ Pd New Formulation

Histex™ Pd New Formulation
SPL v3
SPL
SPL Set ID 0c693f15-5d76-3dbf-e063-6294a90af9ac
Route
ORAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triprolidine (1.25 mg)
Inactive Ingredients
Sucralose Sodium Benzoate Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Citrate, Unspecified Form Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-13

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children.

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

Section 50566-9

Stop use and ask a doctor if

  • new symptoms occur
Section 50567-7

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • sedatives and tranquilizers may increase the drowsiness effect
Section 50568-5

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

Section 50569-3

Ask a doctor before use if the child has

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
Section 50570-1

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

  • use only the enclosed dropper.
  • do not use enclosed dropper for any other drug products.
AGE DOSE
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.

Active Ingredient (in Each 1 Ml Dropperful)

Triprolidine HCl 1.25 mg

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


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • new symptoms occur
Section 50567-7 (50567-7)

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • sedatives and tranquilizers may increase the drowsiness effect
Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
Section 50570-1 (50570-1)

Do not exceed recommended dosage.

Purpose

Antihistamine

Directions

Do not exceed recommended dosage.

  • use only the enclosed dropper.
  • do not use enclosed dropper for any other drug products.
AGE DOSE
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 (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.

Active Ingredient (in Each 1 Ml Dropperful) (Active ingredient (in each 1 mL dropperful))

Triprolidine HCl 1.25 mg

Principal Display Panel 30 Ml Bottle Carton (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)