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

Description

NDC 58809-651-50 Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

NDC 58809-651-50 Drug Facts

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

Section 42229-5

NDC 58809-651-50

Drug Facts

Warnings

Do not exceed recommended dosage.

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

Questions Or Comments?

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

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

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

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

Section 42229-5 (42229-5)

NDC 58809-651-50

Drug Facts

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

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

Questions Or Comments? (Questions or comments?)

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

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

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)