4 Kids Earache Relief

Matricaria Chamomilla,ferric Phosphate,sulfur,oyster Shell Calcium Carbonate, Crude,lycopodium Clavatum Spore And Anemone Pulsatilla

Hyland's Inc.
Human Otc Drug
NDC 54973-3393

4 Kids Earache Relief also known as Matricaria Chamomilla,ferric Phosphate,sulfur,oyster Shell Calcium Carbonate, Crude,lycopodium Clavatum Spore And Anemone Pulsatilla is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for 4 Kids Earache Relief is 54973-3393. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in 4 Kids Earache Relief drug includes Anemone Pulsatilla - 30 [hp_C]/1 Ferrosoferric Phosphate - 30 [hp_C]/1 Lycopodium Clavatum Spore - 30 [hp_C]/1 Matricaria Chamomilla - 30 [hp_C]/1 Oyster Shell Calcium Carbonate, Crude - 30 [hp_C]/1 Sulfur - 30 [hp_C]/1 . The currest status of 4 Kids Earache Relief drug is Active.

Drug Information:

Drug NDC:	54973-3393
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:	Matricaria Chamomilla,ferric Phosphate,sulfur,oyster Shell Calcium Carbonate, Crude,lycopodium Clavatum Spore And Anemone Pulsatilla
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Hyland's Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
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]/1 FERROSOFERRIC PHOSPHATE - 30 [hp_C]/1 LYCOPODIUM CLAVATUM SPORE - 30 [hp_C]/1 MATRICARIA CHAMOMILLA - 30 [hp_C]/1 OYSTER SHELL CALCIUM CARBONATE, CRUDE - 30 [hp_C]/1 SULFUR - 30 [hp_C]/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
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 Dec, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	09 May, 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:	Hyland's Inc.
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:	0354973339316
UPC stands for Universal Product Code.
UNII:	I76KB35JEV 91GQH8I5F7 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
54973-3393-1	1 BOTTLE, PLASTIC in 1 CARTON (54973-3393-1) / 40 TABLET in 1 BOTTLE, PLASTIC	01 Dec, 2018	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

Matricaria Chamomilla & more..

Tablet
Hyland's Inc.
NDC: 54973-3393

Purpose:

Purpose calcarea carbonica 30c hpus.....................................................throbbing ear pain chamomilla 30c hpus ...............................occasional sleeplessness and irritability ferrum phosphoricum 30c hpus...........................................................minor fever lycopodium 30c hpus................................................................................ear pain pulsatilla 30c hpus.............................ear itching, pain worse at night, minor fever sulphur 30c hpus...............................................ear pain with burning, minor fever

Product Elements:

4 kids earache relief matricaria chamomilla,ferric phosphate,sulfur,oyster shell calcium carbonate, crude,lycopodium clavatum spore and anemone pulsatilla acacia lactose monohydrate anhydrous lactose matricaria chamomilla matricaria chamomilla ferrosoferric phosphate ferrosoferric phosphate lycopodium clavatum spore lycopodium clavatum spore anemone pulsatilla anemone pulsatilla oyster shell calcium carbonate, crude oyster shell calcium carbonate, crude sulfur sulfur to off-white

Indications and Usage:

Uses temporarily relieves the symptoms of: minor fever, ear pain or throbbing, occasional sleeplessness or irritability associated with earaches after diagnosis by a physician

Warnings:

Warnings as with any drug, ask a doctor before use if pregnant or breast-feeding. consult a physician if symptoms persist for more than 48 hours or worsen. ï® discharge from ear is present. ï® symptoms are accompanied by a high fever (over 101Âºf). keep this and all medications out of reach of children. in case of accidental overdose, contact a medical professional or poison control center immediately. do not use if imprinted tamper-evident bottle cap band is broken or missing. the inner packaged bottle is child resistant. in case of emergency contact a medical professional or poison control center immediately. hylandâs may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Do Not Use:

Dosage and Administration:

Directions children 2 years to under 6 years dissolve 2 tablets under tongue every 8 hours until relieved for up to 48 hours. children 6 years to under 12 years dissolve 3 tablets under tongue every 8 hours until relieved for up to 48 hours. adults and children 12 years and over dissolve 4 tablets under tongue every 8 hours until relieved for up to 48 hours.

Package Label Principal Display Panel:

Principal display panel - 40 tablets bottle carton new! ndc 54973-3393-1 homeopathic ages 2-12 natural relief since 1903 hyland's 4 kids earache relief* ear pain fever irritability 40 quick-dissolving tablets actual size 194 mg 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.