FDA.reportPublic FDA data

Childrens PediaClear Cough

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 00:19:31

Label at a glance#

ProductChildrens PediaClear Cough
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold

Dosage and administration

take every 4 hours, or as directed by a doctor do not take more than 6 doses in 24 hours or as directed by a doctor do not give more than directed or exceed the recommended daily dosage use only with enclosed dropper do not use enclosed dropper for any other drug product Children 6 to under 12 years of age: 2 mL (2 dropperfuls) Children under 6 years of age: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

CHILDREN’S PEDIACLEAR COUGH

NDC 58809-750-50

Drug Facts

Active ingredients (in each 1 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 6.25 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

WARNINGS SECTION

may cause excitability, especially in children

Do not use

OTC - DO NOT USE SECTION

  • to sedate or make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • a cough that lasts or is chronic such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus)
  • Ask a doctor before use 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

  • symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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 4 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours or as directed by a doctor
  • do not give more than directed or exceed the recommended daily dosage
  • use only with enclosed dropper
  • do not use enclosed dropper for any other drug product
  • Children 6 to under 12 years of age: 2 mL (2 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 under cap 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

Professional Labeling

Use Only as Directed by a Doctor.

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58809-750-50
Children’s
PediaClear
Cough
Liquid drops
1.69 fl. oz. (50 mL)

PRINCIPAL DISPLAY PANEL NDC 58809-750-50 Children’s PediaClear Cough Liquid drops 1.69 fl. oz. (50 mL)PRINCIPAL DISPLAY PANEL NDC 58809-750-50 Children’s PediaClear Cough Liquid drops 1.69 fl. oz. (50 mL)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-750-50ML - Milliliter58809-7506934c624-110d-4c98-8037-efc5b3e2044712019-08-06

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
58809-75058809-750-50

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

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
ab972f54-3093-6ba8-e053-2a95a90a8f4d158246bb-2c7e-41a1-8798-fa21da20f93b2020-07-29WarningsExact identifier
spl set id: 158246bb-2c7e-41a1-8798-fa21da20f93b

Reported adverse events (FAERS/openFDA)#

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