Chamomilla
Matricaria Chamomilla
Hyland's Inc.
Human Otc Drug
NDC 54973-3347Chamomilla also known as Matricaria Chamomilla is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Chamomilla is 54973-3347. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Chamomilla drug includes Matricaria Chamomilla - 6 [hp_X]/1 . The currest status of Chamomilla drug is Active.
Drug Information:
| Drug NDC: | 54973-3347 |
| 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: | Chamomilla |
| 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 |
| 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: | MATRICARIA CHAMOMILLA - 6 [hp_X]/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: | 02 Feb, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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. |
| UNII: | G0R4UBI2ZZ
|
| 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 |
|---|
| 54973-3347-1 | 1 BOTTLE, PLASTIC in 1 CARTON (54973-3347-1) / 125 TABLET in 1 BOTTLE, PLASTIC | 02 Feb, 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. |
Purpose:
Relief of occasional sleeplessness, fussiness and irritability
Product Elements:
Chamomilla matricaria chamomilla lactose monohydrate anhydrous lactose acacia matricaria chamomilla matricaria chamomilla white to off-white
Indications and Usage:
Uses temporarily relieves the symptoms of occasional sleeplessness, fussiness, and irritability
Warnings:
Warnings do not use: ï® â¢ more than directed. ï® â¢ if you have a known allergy to any ingredient in this product. consult a physician if symptoms persist for more than 7 days or worsen. keep this and all medications out of the reach of children. in case of accidental overdose, contact a medical professional or poison control center immediately. do not use if imprinted tamper band is broken or missing. 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:
Warnings do not use: ï® â¢ more than directed. ï® â¢ if you have a known allergy to any ingredient in this product. consult a physician if symptoms persist for more than 7 days or worsen. keep this and all medications out of the reach of children. in case of accidental overdose, contact a medical professional or poison control center immediately. do not use if imprinted tamper band is broken or missing. 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.
Dosage and Administration:
Directions children under 6 months of age: consult a licensed health care professional before using this product. children 6 months to 2 years of age: dissolve 2 tablets under tongue every 15 minutes for 3 doses, then 2-3 times daily until relieved.
Package Label Principal Display Panel:
Principal display panel - 125 tablet bottle carton new! ndc 54973-3347-1 homeopathic since 1903 hyland's® baby natural relief comfort chamomilla one active ingredient relief of occasional sleeplessness, fussiness and irritability* no artificial flavors, dyes or parabens actual size 65 mg 125 quick-dissolving tablets carton
Further Questions:
Questions or comments? (800) 624-9659