NDC 54973-4020 4 Kids Sore Throat Grape

Spongia Officinalis Skeleton, Roasted, Aconitum Napellus, Phosphorus, Calcium Sulfide And Ferrosoferric Phosphate

NDC Product Code 54973-4020

NDC CODE: 54973-4020

Proprietary Name: 4 Kids Sore Throat Grape 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: Spongia Officinalis Skeleton, Roasted, Aconitum Napellus, Phosphorus, Calcium Sulfide And Ferrosoferric Phosphate 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

  • 54973 - Hyland's Inc.

NDC 54973-4020-1

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 118 mL in 1 BOTTLE, PLASTIC

NDC Product Information

4 Kids Sore Throat Grape with NDC 54973-4020 is a a human over the counter drug product labeled by Hyland's Inc.. The generic name of 4 Kids Sore Throat Grape is spongia officinalis skeleton, roasted, aconitum napellus, phosphorus, calcium sulfide and ferrosoferric phosphate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Hyland's 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.

4 Kids Sore Throat Grape 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.

  • FERROSOFERRIC PHOSPHATE 12 [hp_X]/mL
  • CALCIUM SULFIDE 12 [hp_X]/mL
  • PHOSPHORUS 9 [hp_X]/mL
  • ACONITUM NAPELLUS 15 [hp_X]/mL
  • SPONGIA OFFICINALIS SKELETON, ROASTED 12 [hp_X]/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.

  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • WATER (UNII: 059QF0KO0R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)

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.
  • 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: Hyland's Inc.
Labeler Code: 54973
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 02-14-2020 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: 12-31-2021 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.

4 Kids Sore Throat Grape Product Label Images

4 Kids Sore Throat Grape 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

Aconitum Napellus 15X HPUSFerrum Phosphoricum 12X HPUSHepar Sulphuris Calcareum 12X HPUSPhosphorus 9X HPUSSpongia Tosta 12X HPUSHPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Purpose

Sore throatsore throatsore throatpain in throatsore throat

Uses

  • Temporarily relieves sore throat symptoms in children, including: occasional minor irritation pain

Warnings

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Other

Do not use more than directed

  • Consult a physician if:symptoms persist for more than 7 days or worsen.inflammation, fever or infection develops.symptoms are accompanied by a high fever (over 101°F).

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly.

In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Otc - Keep Out Of Reach Of Children

Keep this and all medications out of the reach of children.

Directions

  • Shake well before using.Measure only with the dosing cup provided.Do not use dosing cup with other products.On dosing cup, mL = milliliter.Children 2 yearsto under 6 years5 mL up to 6 times per day (every 4 hours).Children 6 yearsto under 12 years10 mL up to 6 times per day (every 4 hours).Adults and children12 years and over15 mL up to 6 times per day (every 4 hours).

Other Information

  • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.The inner packaged bottle is child-resistant.Store at room temperature.Do not refrigerate.

Inactive Ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.

* Please review the disclaimer below.