4 Kids Earache Relief

Atropa Belladonna,oyster Shell Calcium Carbonate, Crude,lycopodium Clavatum Spore,anemone Pulsatilla,sulfur And Matricaria Chamomilla

Hylands
Human Otc Drug
NDC 54973-3392

4 Kids Earache Relief also known as Atropa Belladonna,oyster Shell Calcium Carbonate, Crude,lycopodium Clavatum Spore,anemone Pulsatilla,sulfur And Matricaria Chamomilla is a human otc drug labeled by 'Hylands'. National Drug Code (NDC) number for 4 Kids Earache Relief is 54973-3392. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in 4 Kids Earache Relief drug includes Anemone Pulsatilla - 30 [hp_C]/mL Atropa Belladonna - 30 [hp_C]/mL Lycopodium Clavatum Spore - 30 [hp_C]/mL Matricaria Chamomilla - 30 [hp_C]/mL Oyster Shell Calcium Carbonate, Crude - 30 [hp_C]/mL Sulfur - 30 [hp_C]/mL . The currest status of 4 Kids Earache Relief drug is Active.

Drug Information:

Drug NDC:	54973-3392
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	4 Kids Earache Relief
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Atropa Belladonna,oyster Shell Calcium Carbonate, Crude,lycopodium Clavatum Spore,anemone Pulsatilla,sulfur And Matricaria Chamomilla
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Hylands
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Liquid
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ANEMONE PULSATILLA - 30 [hp_C]/mL ATROPA BELLADONNA - 30 [hp_C]/mL LYCOPODIUM CLAVATUM SPORE - 30 [hp_C]/mL MATRICARIA CHAMOMILLA - 30 [hp_C]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE - 30 [hp_C]/mL SULFUR - 30 [hp_C]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	AURICULAR (OTIC)
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	01 Mar, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	24 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Hylands
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0354973339217
UPC stands for Universal Product Code.
UNII:	I76KB35JEV WQZ3G9PF0H C88X29Y479 G0R4UBI2ZZ 2E32821G6I 70FD1KFU70
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
54973-3392-1	1 BOTTLE, DROPPER in 1 CARTON (54973-3392-1) / 10 mL in 1 BOTTLE, DROPPER	01 Mar, 2019	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

4 Kids Earache Relief

Atropa Belladonna & more..

Liquid
Hylands
NDC: 54973-3392

Purpose:

Purpose relieves earache due to swimmerâs ear, cold, flu & allergy

Product Elements:

4 kids earache relief atropa belladonna,oyster shell calcium carbonate, crude,lycopodium clavatum spore,anemone pulsatilla,sulfur and matricaria chamomilla water citric acid monohydrate glycerin sodium benzoate atropa belladonna atropa belladonna oyster shell calcium carbonate, crude oyster shell calcium carbonate, crude matricaria chamomilla matricaria chamomilla anemone pulsatilla anemone pulsatilla sulfur sulfur lycopodium clavatum spore lycopodium clavatum spore

Indications and Usage:

Uses temporarily relieves symptoms of earache in children, including: â minor fever â ear pain or throbbing â common pain or itching of "swimmerâs ear" â irritability or occasional sleeplessness associated with earaches after diagnosis by a physician

Warnings:

Warnings keep away from eyes. do not take by mouth. earache drops are only to be used in ears. as with any drug, ask a doctor before use if pregnant or breast-feeding. do not use if you have ear tubes, damaged ear drums or after ear surgery. consult a physician if: â symptoms persist for more than 48 hours or worsen. â discharge from ear is present. â symptoms are accompanied by a high fever (over 101Â°f).

Do Not Use:

Dosage and Administration:

Directions â shake well before using. children ages 2 years and over: tilt head sideways and apply 3-4 drops into involved ear (tip of applicator should not enter ear canal). keep head tilted for at least 2 minutes to keep drops in ear. repeat until relieved, up to 4 times daily.

Package Label Principal Display Panel:

Principal display panel homeopathic ndc 54973-3392-1 2-12 years new look 4 kids since 1903 hyland's earache relief* relieves earache due to swimmerâs ear, cold, flu & allergy no dyes or parabens no numbing effect natural relief* 0.33 fl. oz. (10 ml) *see note on side panel below drug facts carton

Further Questions:

Questions or comments? (800) 624-9659

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.