triprolidine hcl drops

SPL v3

SPL

SPL Set ID f66a4235-d1a5-d2fa-e053-2a95a90a67f9

Route

oral

Published

Effective Date 2023-03-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

triprolidine (1.25 mg)

Inactive Ingredients

anhydrous citric acid glycerin propylene glycol water sodium benzoate sodium citrate saccharin sodium sorbitol

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2023-03-08

Purpose

Antihistamine

Description

Triprolidine HCl Drops NDC 71321-701-50

Medication Information

Warnings

Do not exceed recommended dosage.

Uses

■ temporarily relieves these symptoms due to hay fever

(allergic rhinitis) or other upper respiratory allergies:

■ runny nose ■ itching of the nose or throat

■ sneezing ■ itchy, watery eyes

Purpose

Antihistamine

Directions

■ use only with enclosed dropper ■ mL= milliliter

■ do not use dropper for any other drug product

children 6 to under 12 years: 2 mL every 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor.

children under 6: ask a doctor.

Other Information

■ read all product information before using

■ this packaging is child-resistant.

■ store at room temperature 20-30°C (68-86°F)

Inactive Ingredients

citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution

Description

Triprolidine HCl Drops NDC 71321-701-50

Principal Display Panel

NDC 71321-701-50

Triprolidine HCl Drops

1.69 fl oz (50 mL)

Section 42229-5

Triprolidine HCl Drops

NDC 71321-701-50

Active Ingredients

Triprolidine HCI 1.25 mg

Questions Or Comments?

Call 610-314-7943 9 a.m. - 5 p.m. EST.

When Using This Product

■ excitability may occur, especially in children

■ marked drowsiness may occur

■ sedatives and tranquilizers may increase the drowsiness effect

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.

Ask A Doctor Before Use If the Child Is

taking sedatives or tranquilizers

Ask A Doctor Before Use If the Child Has

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

■ trouble urinating due to an enlarged prostate

Structured Label Content

Warnings

Do not exceed recommended dosage.

Uses

■ temporarily relieves these symptoms due to hay fever

(allergic rhinitis) or other upper respiratory allergies:

■ runny nose ■ itching of the nose or throat

■ sneezing ■ itchy, watery eyes

Purpose

Antihistamine

Directions

■ use only with enclosed dropper ■ mL= milliliter

■ do not use dropper for any other drug product

children 6 to under 12 years: 2 mL every 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor.

children under 6: ask a doctor.

Other Information (Other information)

■ read all product information before using

■ this packaging is child-resistant.

■ store at room temperature 20-30°C (68-86°F)

Inactive Ingredients (Inactive ingredients)

citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 71321-701-50

Triprolidine HCl Drops

1.69 fl oz (50 mL)

Section 42229-5 (42229-5)

Triprolidine HCl Drops

NDC 71321-701-50

Active Ingredients (Active ingredients)

Triprolidine HCI 1.25 mg

Questions Or Comments? (Questions or comments?)

Call 610-314-7943 9 a.m. - 5 p.m. EST.

When Using This Product (When using this product)

■ excitability may occur, especially in children

■ marked drowsiness may occur

■ sedatives and tranquilizers may increase the drowsiness effect

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ new symptoms occur

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If the Child Is (Ask a doctor before use if the child is)

taking sedatives or tranquilizers

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

■ trouble urinating due to an enlarged prostate

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "■ temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: ■ runny nose ■ itching of the nose or throat ■ sneezing ■ itchy, watery eyes", "42229-5": "Triprolidine HCl Drops NDC 71321-701-50", "Purpose": "Antihistamine", "Warnings": "Do not exceed recommended dosage.", "Directions": "■ use only with enclosed dropper ■ mL= milliliter ■ do not use dropper for any other drug product children 6 to under 12 years: 2 mL every 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor. children under 6: ask a doctor.", "Other information": "■ read all product information before using ■ this packaging is child-resistant. ■ store at room temperature 20-30°C (68-86°F)", "Active ingredients": "Triprolidine HCI 1.25 mg", "Inactive ingredients": "citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution", "Questions or comments?": "Call 610-314-7943 9 a.m. - 5 p.m. EST.", "PRINCIPAL DISPLAY PANEL": "NDC 71321-701-50 Triprolidine HCl Drops 1.69 fl oz (50 mL)", "When using this product": "■ excitability may occur, especially in children ■ marked drowsiness may occur ■ sedatives and tranquilizers may increase the drowsiness effect", "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.", "Ask a doctor before use if the child is": "taking sedatives or tranquilizers", "Ask a doctor before use if the child has": "■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ trouble urinating due to an enlarged prostate"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:40.655408 · Updated: 2026-03-14T23:02:21.986500