Baby Nighttime Mucus Plus Cold Relief

Calcium Sulfide,phosphorus,sulfur,rumex Crispus Root,sodium Chloride,arabica Coffee Bean,anemone Pulsatilla,silicon Dioxide, Goldenseal,onion,bryonia Alba Root,euphrasia Stricta And Matricaria Chamomilla

Hyland's Inc.
Human Otc Drug
NDC 54973-3371

Baby Nighttime Mucus Plus Cold Relief also known as Calcium Sulfide,phosphorus,sulfur,rumex Crispus Root,sodium Chloride,arabica Coffee Bean,anemone Pulsatilla,silicon Dioxide, Goldenseal,onion,bryonia Alba Root,euphrasia Stricta And Matricaria Chamomilla is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Baby Nighttime Mucus Plus Cold Relief is 54973-3371. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Baby Nighttime Mucus Plus Cold Relief drug includes Anemone Pulsatilla - 6 [hp_X]/mL Arabica Coffee Bean - 3 [hp_X]/mL Bryonia Alba Root - 6 [hp_X]/mL Calcium Sulfide - 12 [hp_X]/mL Euphrasia Stricta - 6 [hp_X]/mL Goldenseal - 6 [hp_X]/mL Matricaria Chamomilla - 3 [hp_X]/mL Onion - 6 [hp_X]/mL Phosphorus - 30 [hp_X]/mL Rumex Crispus Root - 6 [hp_X]/mL and more. The currest status of Baby Nighttime Mucus Plus Cold Relief drug is Active.

Drug Information:

Drug NDC:	54973-3371
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 Mucus Plus Cold 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:	Calcium Sulfide,phosphorus,sulfur,rumex Crispus Root,sodium Chloride,arabica Coffee Bean,anemone Pulsatilla,silicon Dioxide, Goldenseal,onion,bryonia Alba Root,euphrasia Stricta And 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:	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 - 6 [hp_X]/mL ARABICA COFFEE BEAN - 3 [hp_X]/mL BRYONIA ALBA ROOT - 6 [hp_X]/mL CALCIUM SULFIDE - 12 [hp_X]/mL EUPHRASIA STRICTA - 6 [hp_X]/mL GOLDENSEAL - 6 [hp_X]/mL MATRICARIA CHAMOMILLA - 3 [hp_X]/mL ONION - 6 [hp_X]/mL PHOSPHORUS - 30 [hp_X]/mL RUMEX CRISPUS ROOT - 6 [hp_X]/mL Load more... SILICON DIOXIDE - 12 [hp_X]/mL SODIUM CHLORIDE - 6 [hp_X]/mL SULFUR - 12 [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 Nov, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	08 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.
NUI:	N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0516536 M0022575
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	I76KB35JEV 3SW678MX72 T7J046YI2B 1MBW07J51Q C9642I91WL ZW3Z11D0JV G0R4UBI2ZZ 492225Q21H 27YLU75U4W 9N1RM2S62C Load more... ETJ7Z6XBU4 451W47IQ8X 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.
Pharmacologic Class EPC:	Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Seed Storage Proteins [CS] Vegetable Proteins [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Seed Storage Proteins [CS] Vegetable Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
54973-3371-2	1 BOTTLE, PLASTIC in 1 CARTON (54973-3371-2) / 118 mL in 1 BOTTLE, PLASTIC	01 Nov, 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

Baby Mucus Plus Cold Relief Daytime And Nighttime

Calcium Sulfide & more..

Kit
Hyland's Inc.
NDC: 54973-3374

Baby Nighttime Mucus Plus Cold Relief

Calcium Sulfide & more..

Liquid
Hyland's Inc.
NDC: 54973-3371

Purpose:

Purpose relieves mucus, congestion, runny nose, sneezing, cough and occasional sleeplessness

Product Elements:

Baby nighttime mucus plus cold relief calcium sulfide,phosphorus,sulfur,rumex crispus root,sodium chloride,arabica coffee bean,anemone pulsatilla,silicon dioxide, goldenseal,onion,bryonia alba root,euphrasia stricta and matricaria chamomilla water glycyrrhiza glabra citric acid monohydrate glycerin sodium benzoate calcium sulfide calcium sulfide phosphorus phosphorus anemone pulsatilla anemone pulsatilla silicon dioxide silicon dioxide goldenseal goldenseal onion onion bryonia alba root bryonia alba root euphrasia stricta euphrasia stricta matricaria chamomilla matricaria chamomilla arabica coffee bean arabica coffee bean sodium chloride chloride ion rumex crispus root rumex crispus root sulfur sulfur

Indications and Usage:

Uses â temporarily relieves symptoms of common cold in children at night, including: â accumulation of mucus in chest, throat or nose â cough with mucus â runny nose â sneezing â nasal or chest congestion â occasional sleeplessness

Warnings:

Warnings sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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. â 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:

Package label - 4 fl oz (118 ml) bottle carton hyland's naturalsâ¢ â¢babyâ¢ mucus + cold relief* nighttime no sugar, paraben or dyes sleeplessness mucus congestion runny nose sneezing cough 6+ months 4 fl. oz. (118 ml) less than 0.2% alcohol | 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.