FDA.reportPublic FDA data

Childrens PediaClear 8

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 01:15:49

Label at a glance#

ProductChildrens PediaClear 8
Active ingredientPYRILAMINE MALEATE
Label structure10 sections

Indications and uses

■ temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

Dosage and administration

■ mL= milliliter ■ use enclosed 15 mL dose cup and keep with product ■ children 6 to under 12 years: 30 mL (2 dose cups) every 6 to 8 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor ■ children under 6 years of age: consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

CHILDRENS PEDIACLEAR 8

NDC: 58809-770-08

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

 (in each 15 mL)

Pyrilamine Maleate 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

Warnings

WARNINGS SECTION

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

■ marked drowsiness may occur

■ sedatives and tranquilizers may increase drowsiness

■ excitability may occur, especially in children

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

■ mL= milliliter
■ use enclosed 15 mL dose cup and keep with product
■ children 6 to under 12 years: 30 mL (2 dose cups) every 6 to 8 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor
■ children under 6 years of age: consult a doctor.

Other information

OTHER SAFETY INFORMATION

■ each 15 mL contains: Sodium 6 mg
■ 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, sorbitol, sucralose

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 58809-770-08

Children’s

PediaClear

8 Eight

8 fl oz (237 mL)

PDP1PDP1

Drug FactsDrug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2178281PediaClear 12.5 MG in 15 mL Oral SolutionPSN9
2178279pyrilamine maleate 12.5 MG in 15 mL Oral SolutionPSN9
2178281pyrilamine maleate 0.833 MG/ML Oral Solution [Pediaclear]SBD9
2178279pyrilamine maleate 0.833 MG/ML Oral SolutionSCD9
2178281Pediaclear 0.833 MG/ML Oral SolutionSY9
2178281Pediaclear 12.5 MG per 15 mL Oral SolutionSY9
2178279pyrilamine maleate 12.5 MG per 15 mL Oral SolutionSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-770-08Childrens PediaClear 8237 mL in 1 BOTTLELIQUID2379

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-770-08ML - Milliliter58809-770aa10cc27-d748-4478-83a6-231f5b1849f212019-08-06

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
58809-77058809-770-08

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
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
PYRILAMINE MALEATER35D29L3ZAACTIB

Source Document#

Source XML

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 8PYRILAMINE MALEATEGM Pharmaceuticals, INC8e524967-d01c-4c93-9198-c42f15fe3fe02025-10-03WarningsExact identifier
ndc (package): 58809-770-08
ndc (product): 58809-770
ndc11 (package): 58809077008
spl id: 404600cf-672a-ccf7-e063-6394a90a1b51
spl set id: 8e524967-d01c-4c93-9198-c42f15fe3fe0

Reported adverse events (FAERS/openFDA)#

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