FDA.reportPublic FDA data

Childrens PediaClear PD

Manufacturer
GM Pharmaceuticals, INC
Effective date
2025-10-03
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:15:53

Label at a glance#

ProductChildrens PediaClear PD
Active ingredientTRIPROLIDINE HYDROCHLORIDE
Label structure10 sections

Indications and 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

Dosage and administration

■ 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58809-651-50

Drug Facts

Active ingredients (in each 2 mL)

OTC - ACTIVE INGREDIENT SECTION

Triprolidine HCI 1.25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

■ 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

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

Ask a doctor before use if the child is

SPL UNCLASSIFIED SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ 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

OTC - STOP USE SECTION

■ new symptoms occur

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ use only with enclosed dropper   ■ mL= milliliter

■ do not use dropper for any other drug product

AgeDose
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 SAFETY 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 INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58809-651-50
Children’s PediaClear PD Drops

1.69 fl oz (50 mL)

Children’s PediaClear PD Drops Label

Pediaclear PD PDPPediaclear PD PDP

Children’s PediaClear PD Drops Drug Facts

Pediaclear PD Drug FactsPediaclear PD Drug Facts

Children’s PediaClear PD Drops Carton

Pediaclear PD Drug FactsPediaclear PD Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2179647Pediaclear Childrens PD 1.25 MG in 2 mL Oral SolutionPSN9
1428927triprolidine HCl 0.625 MG in 1 mL Oral SolutionPSN9
2179647triprolidine hydrochloride 0.625 MG/ML Oral Solution [Pediaclear Childrens]SBD9
1428927triprolidine hydrochloride 0.625 MG/ML Oral SolutionSCD9
2179647Pediaclear Childrens 0.625 MG/ML Oral SolutionSY9
1428927triprolidine hydrochloride 0.625 MG per 1 ML Oral SolutionSY9
1428927triprolidine hydrochloride 1.25 MG per 2 ML Oral SolutionSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-651-50Childrens PediaClear PD50 mL in 1 BOTTLE, DROPPERLIQUID509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-651-50ML - Milliliter58809-651b3f40ab3-c336-41c2-94b7-110bea7d751b12019-09-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58809-65158809-651-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens PediaClear PDTRIPROLIDINE HYDROCHLORIDEGM Pharmaceuticals, INCf3ede5b7-1b0f-493a-b647-4459affc7e542025-10-03WarningsExact identifier
ndc (package): 58809-651-50
ndc (product): 58809-651
ndc11 (package): 58809065150
spl id: 40464d7d-2e3f-4c29-e063-6294a90a6dd2
spl set id: f3ede5b7-1b0f-493a-b647-4459affc7e54

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.