NDC 58809-750 Childrens Pediaclear Cough

Diphenhydramine Hydrochloride

NDC Product Code 58809-750

NDC Code: 58809-750

Proprietary Name: Childrens Pediaclear Cough What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Diphenhydramine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 58809 - Gm Pharmaceuticals, Inc
    • 58809-750 - Childrens Pediaclear Cough

NDC 58809-750-50

Package Description: 50 mL in 1 BOTTLE, DROPPER

NDC Product Information

Childrens Pediaclear Cough with NDC 58809-750 is a a human over the counter drug product labeled by Gm Pharmaceuticals, Inc. The generic name of Childrens Pediaclear Cough is diphenhydramine hydrochloride. 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 Cough 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 6.25 mg/mL

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 Cough 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 1 Ml)

Diphenhydramine HCl 6.25 mg

Purpose

Cough Suppressant

Uses

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

Warnings

May cause excitability, especially in children

Do Not Use

  • To sedate or make a child sleepywith any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If Your Child Has

  • 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

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

Stop Use And Ask A Doctor If:

  • 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,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Take every 4 hours, or as directed by a doctordo 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 dosageuse only with enclosed dropper do not use enclosed dropper for any other drug productChildren 6 to under 12 years of age: 2 mL (2 dropperfuls)Children under 6 years of age: ask a doctor

Other 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

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

Questions?

  • Call 1-888-535-0305 9 a. m. - 5 p. m. CSTProfessional LabelingUse Only as Directed by a Doctor.Children 2 to under 6: 1 mL (1 dropperful) years of ageChildren under 2 years of age: Not RecommendedTake every 4 hours.Do not exceed 6 doses in 24 hours.

* Please review the disclaimer below.

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