Childrens Pediaclear 8 Liquid
FDA Label NDC 58809-770

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 8 (NDC 58809-770). 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, purpose, uses, 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, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

 (in each 15 mL)

Pyrilamine Maleate 12.5 mg

Purpose

Antihistamine

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.

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

■ marked drowsiness may occur

■ sedatives and tranquilizers may increase drowsiness

■ excitability may occur, especially in children

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 dose cup and keep with product

■ mL= milliliter

■ professional labeling: for use under guidance of health professional only children 6 to under 12 years of age: 30 mL (2 dose cups) every 6 to 8 hours, not to exceed 4 doses in 24 hours. children 2 to under 6 years of age:15 mL (1 dose cup) every 6 to 8 hours, not to exceed 4 doses in 24 hours.

Other Information

■ each 15 mL contains: Sodium 6 mg

■ 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, sorbitol, sucralose

Questions Or Comments?

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

Principal Display Panel

NDC 58809-770-08
Children’s
PediaClear
8 Eight
8 fl oz (237 mL)

* Please review the disclaimer below.