Childrens PediaClear Allergy

Manufacturer
GM Pharmaceuticals, INC
Effective date
2019-06-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:19:35

Label at a glance#

ProductChildrens PediaClear Allergy
Active ingredientTRIPROLIDINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves: runny nose sneezing itching of nose and throat itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis

Dosage and administration

 take every 6 hours  do not take more than 4 doses in 24 hours or as directed by a doctor  do not give more than directed or exceed the recommended daily dosage Children 6 to under 12 years of age: 4 mL (4 dropperfuls) Children under 6 years of age: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Children’s PediaClear Allergy

NDC 58809-740-50

Antihistamine

50 mL

Active ingredients (in each 1 mL)

OTC - ACTIVE INGREDIENT SECTION

Triprolidine HCl  0.313 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves:
  • runny nose
  • sneezing
  • itching of nose and throat
  • itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis

Warnings

WARNINGS SECTION

  •  May cause excitability, especially in children

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor before use

SPL UNCLASSIFIED SECTION

if the child is taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  •  do not use more than directed
  • may cause marked drowsiness
  • sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if: 

OTC - STOP USE SECTION

  • new symptoms occur

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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

  •  take every 6 hours
  •  do not take more than 4 doses in 24 hours or as directed by a doctor
  •  do not give more than directed or exceed the recommended daily dosage
  • Children 6 to under 12 years of age: 4 mL (4 dropperfuls)
  • Children under 6 years of age: ask a doctor

Other Information

OTHER SAFETY INFORMATION

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • Tamper Evident: Do not use if seal is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol ,sucralose

Questions?

OTC - QUESTIONS SECTION

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

Distributed by:

GM Pharmaceuticals, Inc.

Arlington, TX 76015

mper evident by foil seal under cap. Do not use if

Professional Labeling

Use Only as Directed by a Doctor

  • Children 4 months to under 2 years of age: 1 mL (1 dropperful)
  • Children 2 to under 4 years of age: 2 mL (2 dropperfuls)
  • Children 4 to under 6 years of age: 3 mL (3 dropperfuls)
  • Take every 6 hours.
  • Do not exceed 4 doses in 24 hours.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58809-740-50
Children’s
PediaClear
Allergy
1.69 fl. oz. (50 mL)

PRINCIPAL DISPLAY PANEL NDC 58809-740-50 Children’s PediaClear Allergy 1.69 fl. oz. (50 mL)PRINCIPAL DISPLAY PANEL NDC 58809-740-50 Children’s PediaClear Allergy 1.69 fl. oz. (50 mL)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-740-50ML - Milliliter58809-7405f9ea2a2-228c-4ae6-a221-a49f1657e13f12019-08-06

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
58809-74058809-740-50

Ingredients#

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

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

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
ad69294e-7f51-4db0-e053-2a95a90a39cf867953d6-8746-45be-b656-336daaa1d9682020-08-21WarningsExact identifier
spl set id: 867953d6-8746-45be-b656-336daaa1d968

Reported adverse events (FAERS/openFDA)#

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