Triprolidine Hcl

Triprolidine Hcl
SPL v6
SPL
SPL Set ID a9f01760-e335-4410-a9b8-8edce2841270
Route
ORAL
Published
Effective Date 2023-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triprolidine (0.938 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Propylene Glycol Water Sucralose Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-09

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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 53414-9

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

Warnings

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 product.
AGE DOSE
Adults & Children 12 years of age or older: 2.67 mL (2.5 milligrams) every 4 to 6 hours, not to exceed 10.67 mL (10 milligrams) in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age: 1.33 mL (1.25 milligrams) every 4 to 6 hours, not to exceed 5.33 mL (5 milligrams) in 24 hours, or as directed by a doctor.
Children under 6 years of age: consult a doctor.
Other Information
  • This packaging is child-resistant.
  • Store at room temperature 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 1-844-221-7294.

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
Ask A Doctor Before Use If You Have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor before use if you are taking sedatives or tranquilizers

Active Ingredient (in Each 1 Ml Dropperful)

Triprolidine HCl 0.938 mg

Principal Display Panel 30 Ml Bottle Carton

NDC 69367-253-30

Triprolidine HCl

Antihistamine

Each dropperful (1 mL) contains:

Triprolidine HCl 0.938 mg

Sugar-Free • Dye Free • Alcohol Free

Tamper evident by foil seal under cap.

Do no use if foil seal is broken or missing.

Bubble Gum Flavor

1 fl oz (30 mL)

Westminster

Pharmaceuticals


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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

Warnings

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 product.
AGE DOSE
Adults & Children 12 years of age or older: 2.67 mL (2.5 milligrams) every 4 to 6 hours, not to exceed 10.67 mL (10 milligrams) in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age: 1.33 mL (1.25 milligrams) every 4 to 6 hours, not to exceed 5.33 mL (5 milligrams) in 24 hours, or as directed by a doctor.
Children under 6 years of age: consult a doctor.
Other Information
  • This packaging is child-resistant.
  • Store at room temperature 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 1-844-221-7294.

When Using This Product (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 (Stop use and ask a doctor if)
  • new symptoms occur
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor before use if you are taking sedatives or tranquilizers

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

Triprolidine HCl 0.938 mg

Principal Display Panel 30 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton)

NDC 69367-253-30

Triprolidine HCl

Antihistamine

Each dropperful (1 mL) contains:

Triprolidine HCl 0.938 mg

Sugar-Free • Dye Free • Alcohol Free

Tamper evident by foil seal under cap.

Do no use if foil seal is broken or missing.

Bubble Gum Flavor

1 fl oz (30 mL)

Westminster

Pharmaceuticals


Advanced Ingredient Data


Raw Label Data

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