Baby Nighttime Tiny Cold

Chamomile, Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodide

Hyland's Inc.
Human Otc Drug
NDC 54973-3180

Baby Nighttime Tiny Cold also known as Chamomile, Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodide is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Baby Nighttime Tiny Cold is 54973-3180. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Baby Nighttime Tiny Cold drug includes Chamomile - 6 [hp_X]/mL Eupatorium Perfoliatum Flowering Top - 6 [hp_X]/mL Euphrasia Stricta - 6 [hp_X]/mL Gelsemium Sempervirens Root - 6 [hp_X]/mL Potassium Iodide - 6 [hp_X]/mL . The currest status of Baby Nighttime Tiny Cold drug is Active.

Drug Information:

Drug NDC:	54973-3180
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 Nighttime Tiny Cold
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:	Chamomile, Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodide
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:	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:	CHAMOMILE - 6 [hp_X]/mL EUPATORIUM PERFOLIATUM FLOWERING TOP - 6 [hp_X]/mL EUPHRASIA STRICTA - 6 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT - 6 [hp_X]/mL POTASSIUM IODIDE - 6 [hp_X]/mL
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 Jul, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 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:	FGL3685T2X 1W0775VX6E C9642I91WL 639KR60Q1Q 1C4QK22F9J
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
54973-3180-1	1 BOTTLE, PLASTIC in 1 CARTON (54973-3180-1) / 118 mL in 1 BOTTLE, PLASTIC	01 Jul, 2014	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

Baby Nighttime Tiny Cold

Chamomile & more..

Liquid
Hyland's Inc.
NDC: 54973-3180

Purpose:

Active ingredients purpose "hpus" indicates that the active ingredients are in the official homeopathic pharmacopÅia of the united states. chamomilla 6x hpus occasional sleeplessness eupatorium perfoliatum 6x hpus headache, cough, sneezing euphrasia officinalis 6x hpus runny eyes and nose gelsemium sempervirens 6x hpus sneezing with stuffy nose kali iodatum 6x hpus headache, runny eyes and nose

Product Elements:

Baby nighttime tiny cold chamomile, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide glycyrrhiza glabra citric acid monohydrate water sodium benzoate glycerin chamomile chamomile 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 temporarily relieves 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 ask a doctor before use if you have: â persistent or chronic cough such as asthma, chronic bronchitis or emphysema. a persistent cough may be a sign of a serious condition. â cough that is accompanied by excessive phlegm (mucus). 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. keep out of reach of children.

Dosage and Administration:

Directions â use as directed. ï® do not refrigerate. â shake well before using. â measure only with the dosing syringe provided. â do not use dosing syringe with other products. â on dosing syringe, ml = milliliter. children under 6 months ask a doctor before use. children 6 months to under 1 year 2.5 ml at bedtime and every 6 hours during the night until relieved. children 1 year to under 3 years 5 ml at bedtime and 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.

Package Label Principal Display Panel:

Principal display panel - 118 ml bottle carton hyland's naturals â¢babyâ¢ tiny cold syrup nighttime no alcohol, sugar, parabens or dyes sleeplessness congestion runny nose sneezing 6+ months 4 fl. oz. (118 ml) homeopathic carton

Further Questions:

Questions? (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.