Triprolidine Hydrochloride Syrup
FDA Label NDC 69367-253

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 69367-253). 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 the child has, 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 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

Otc - Keep Out Of Reach Of Children

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.

  • For dosing, use only the enclosed dropper and not with any other drug product.
    • AGEDOSE
    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

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, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose.

Questions? Comments?

Call 1-844-221-7294.

Principal Display Panel - 30 Ml Bottle Label

NDC 69367-253-30

Triprolidine HCl
Antihistamine
Each dropperful (1 mL) contains:
Triprolidine HCl    0.938 mg
Sugar-Free • Dye Free
Alcohol Free

Bubble Gum Flavor
1 fl oz (30 mL)

Westminster
Pharmaceuticals

Principal Display Panel (30 mL Bottle Label)

Principal Display Panel (30 mL Bottle Label)

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