NDC 58809-770 Childrens Pediaclear 8

Pyrilamine Maleate

NDC Product Code 58809-770

NDC 58809-770-08

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Childrens Pediaclear 8 with NDC 58809-770 is a a human over the counter drug product labeled by Gm Pharmaceuticals, Inc. The generic name of Childrens Pediaclear 8 is pyrilamine maleate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Gm Pharmaceuticals, Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Childrens Pediaclear 8 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PYRILAMINE MALEATE 12.5 mg/15mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Gm Pharmaceuticals, Inc
Labeler Code: 58809
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-25-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Childrens Pediaclear 8 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling 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

* Please review the disclaimer below.