Baby Tiny Cold Daytime And Nighttime
Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, Potassium Iodide, And Matricaria Recutita
Hyland's Inc.
Human Otc Drug
NDC 54973-3307Baby Tiny Cold Daytime And Nighttime also known as Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, Potassium Iodide, And Matricaria Recutita is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Baby Tiny Cold Daytime And Nighttime is 54973-3307. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Baby Tiny Cold Daytime And Nighttime drug includes . The currest status of Baby Tiny Cold Daytime And Nighttime drug is Active.
Drug Information:
| Drug NDC: | 54973-3307 |
| 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: | Baby Tiny Cold Daytime And Nighttime |
| 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: | Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, Potassium Iodide, And Matricaria Recutita |
| 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: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 11 Jan, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| 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: | |
| 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 |
|---|
| 54973-3307-1 | 1 KIT in 1 CARTON (54973-3307-1) * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3158-1) / 125 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3252-1) / 125 TABLET in 1 BOTTLE, PLASTIC | 11 Jan, 2017 | 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:
Helps temporarily relieve symptoms of common cold in children at night, including: runny nose or eyes, cough, nasal congestion, headache, sneezing, occasional sleeplessness.
Product Elements:
Baby tiny cold daytime and nighttime eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, potassium iodide, and matricaria recutita tiny cold eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide lactose, unspecified form acacia eupatorium perfoliatum flowering top eupatorium perfoliatum flowering top euphrasia stricta euphrasia stricta gelsemium sempervirens root gelsemium sempervirens root potassium iodide iodide ion baby nighttime tiny cold matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide acacia lactose, unspecified form matricaria recutita matricaria recutita eupatorium perfoliatum flowering top eupatorium perfoliatum flowering top euphrasia stricta euphrasia stricta gelsemium sempervirens root gelsemium sempervirens root potassium iodide iodide ion
Indications and Usage:
Uses â helps temporarily relieve symptoms of common cold in children, including: â runny nose or eyes â nasal congestion â headache â sneezing â cough
Uses â helps temporarily relieve symptoms of common cold in children at night, including: â runny nose or eyes â cough â nasal congestion â headache â sneezing â occasional sleeplessness
Warnings:
Warnings
Warnings
Dosage and Administration:
Directions â use as directed. children under 6 months: ask a doctor before use. children 6 months to under 1 year: at onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours. if symptoms persist, 2 tablets every 4 hours until relieved. children 1 year to under 3 years: at onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. if symptoms persist, 3 tablets every 4 hours until relieved.
Directions â use as directed children under 6 months: ask a doctor before use. children 6 months to under 1 year: at onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. if symptoms persist, 2 tablets every 4 hours during the night until relieved. children 1 year to under 3 years: at onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. if symptoms persist, 3 tablets every 4 hours during the night until relieved.
Stop Use:
Stop use and ask a doctor if â symptoms persist for more than 72 hours or worsen. â inflammation, fever or infection is present or develops. â cough tends to recur or is accompanied by a fever, rash or persistent headache.
Stop use and ask a doctor if â symptoms persist for more than 72 hours or worsen. â inflammation, fever or infection is present or develops. â cough tends to recur or is accompanied by a fever, rash or persistent headache.
Package Label Principal Display Panel:
Principal display panel hyland's naturals â¢baby⢠tiny cold tablets* combo pack no artificial flavors, parabens or dyes daytime nasal congestion runny nose sneezing cough nighttime sleeplessness nasal congestion runny nose sneezing cough 6+ months 2 x 125 ct bottles (1 day, 1 night) quick-dissolving tablets homeopathic carton
Further Questions:
Questions? www.hylands.com or care@hylands.com