children's pediaclear pd

children's pediaclear pd
SPL v9
SPL
SPL Set ID f3ede5b7-1b0f-493a-b647-4459affc7e54
Route
oral
Published
Effective Date 2022-03-25
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 2019-07-01
Purpose

Antihistamine

Description

NDC 58809-651-50 Drug Facts

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

Age Dose
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

NDC 58809-651-50 Drug Facts

Principal Display Panel

NDC 58809-651-50

Children’s PediaClear PD Drops

1.69 fl oz (50 mL)

Children’s PediaClear PD Drops Label

Children’s PediaClear PD Drops Drug Facts

Children’s PediaClear PD Drops Carton

Section 42229-5

NDC 58809-651-50

Drug Facts

Questions Or Comments?

Call 1-888-535-0305 9 a.m. - 5 p.m. CST.

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.

Active Ingredients (in Each 2 Ml)

Triprolidine HCI 1.25 mg

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

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

Age Dose
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 58809-651-50

Children’s PediaClear PD Drops

1.69 fl oz (50 mL)

Children’s PediaClear PD Drops Label

Children’s PediaClear PD Drops Drug Facts

Children’s PediaClear PD Drops Carton

Section 42229-5 (42229-5)

NDC 58809-651-50

Drug Facts

Questions Or Comments? (Questions or comments?)

Call 1-888-535-0305 9 a.m. - 5 p.m. CST.

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.

Active Ingredients (in Each 2 Ml) (Active ingredients (in each 2 mL))

Triprolidine HCI 1.25 mg

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:12.425446 · Updated: 2026-03-14T23:10:26.709421