Triprolidine Hydrochloride Syrup
FDA Label NDC 69367-450

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Westminster Pharmaceuticals, Llc for the product Triprolidine Hydrochloride (NDC 69367-450). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 1 ml dropperful), purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each 1 Ml Dropperful)

Triprolidine HCl 1.25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other uppser respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

Warnings

Do not exceed recommended dosage.

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

When Using This Product

  • may cause drowsiness
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when drivin a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • new symptoms occur

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).

Directions

  • do not exceed recommended dosage.
  • use only the enclosed dropper
  • do not use enclosed dropper for any other drug product.
    • AGEDOSE
    Adults & Children 12 years of age or older:2.0 mL (2.5 milligrams) every 4 to 6 hours, not to exceed 8 mL (10 milligrams) in 24 hours, or as directed by a doctor.
    Children 6 to under 12 years of age:1.0 mL (1.25 milligrams) every 4 to 6 hours, not to exceed 4 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.

Principal Display Panel - 30 Ml Bottle Carton

NDC 69367-450-30

Triprolidine HCl
Antihistamine

Each dropperful (1 mL) contains:
Triprolidine HCl
1.25 mg

Sugar-Free • Dye Free
Alcohol Free

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing

Bubble Gum Flavor
1 fl oz (30 mL)

Westminster
Pharmaceuticals

Principal Display Panel (30 mL Bottle Carton)

Principal Display Panel (30 mL Bottle Carton)

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