Active Ingredients (In Each 2 Ml)
Triprolidine HCI 1.25 mg
Childrens Pediaclear Pd Liquid
FDA Label NDC 58809-651
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gm Pharmaceuticals, Inc for the product Childrens Pediaclear Pd (NDC 58809-651). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 2 ml), purpose, uses, warnings, ask a doctor before use if the child has, ask a doctor before use if the child is, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
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
Warnings
Do not exceed recommended dosage.
Ask A Doctor Before Use If The Child Has
■ a breathing problem such as emphysema or chronic bronchitis
■ glaucoma
Ask A Doctor Before Use If The Child Is
taking sedatives or tranquilizers
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.
Directions
■ use only with enclosed dropper
■ do not use dropper for any other drug product
■ mL= milliliter
■ Professional Labeling: Take under guidance of health professionals.
children 6 to under 12 years of age: 2 mL every 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor.
children 4 to under 6 years of age: 1.5 mL ever 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor.
children 2 to under 4 years of age: 1 mL ever 6 hours, not to exceed 4 doses in 24 hours
or as directed by a doctor.
infants 4 months to under 2 years of age: .5 mL every 6 hours, not to exceed 4 doses in 24 hours or as directed by a doctor.
Other Information
■ read all product information before using
■ 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
Questions Or Comments?
Call 1-888-535-0305 9 a.m. - 5 p.m. CST.
Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76015
Principal Display Panel
NDC 58809-651-50
Children’s
PediaClear
PD
Drops
1.69 fl oz (50 mL)
* Please review the disclaimer below.
