Baby Mucus Plus Cold Relief Daytime And Nighttime

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 54973-3374
Baby Mucus Plus Cold Relief Daytime And Nighttime 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 Mucus Plus Cold Relief Daytime And Nighttime is 54973-3374. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Baby Mucus Plus Cold Relief Daytime And Nighttime drug includes . The currest status of Baby Mucus Plus Cold Relief Daytime And Nighttime drug is Active.

Drug Information:

Drug NDC: 54973-3374
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 Mucus Plus Cold Relief 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: 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: 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: 01 Nov, 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, 2024
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
54973-3374-11 KIT in 1 CARTON (54973-3374-1) * 118 mL in 1 BOTTLE, PLASTIC (54973-3284-1) * 118 mL in 1 BOTTLE (54973-3371-2)01 Nov, 2018N/ANo
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: accumulation of mucus in chest, throat or nose, cough with mucus, runny nose, sneezing, nasal or chest congestion, occasional sleeplessness.

Product Elements:

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

Indications and Usage:

Uses ■ helps temporarily relieve symptoms of common cold in children, including: ■ accumulation of mucus in chest, throat or nose ■ cough with mucus ■ runny nose ■ sneezing ■ nasal or chest congestion

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

Warnings:

Warnings ask a doctor before use if you have ■ persistent or chronic cough such as asthma, chronic bronchitis or emphysema. a persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus). stop use and ask a doctor if ■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache. keep out of reach of children

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 ■ persistent or chronic cough such as asthma, chronic bronchitis or emphysema. a persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus). stop use and ask a doctor if ■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache. keep out of reach of children

Dosage and Administration:

Directions ■ use as directed. ■ do not refrigerate. ■ shake well before using. ■ measure only with the dosing syringe provided. ■ do not use dosing syringe with other products. ■ on dosing syringe, ml = milliliter. children under 6 months ask a doctor before use. children 6 months to under 1 year 2.5 ml up to 4 times per day (every 6 hours). children 1 year to under 3 years 5 ml up to 6 times per day (every 4 hours).

Directions ■ use as directed. ■ do not refrigerate. ■ shake well before using. ■ measure only with the dosing syringe provided. ■ do not use dosing syringe with other products. ■ 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 ■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

Stop use and ask a doctor if ■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ 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™ •baby• mucus + cold relief* combo pack no sugar, parabens or dyes daytime mucus congestion runny nose sneezing cough nighttime sleeplessness mucus congestion runny nose sneezing cough 6+ months daytime - no alcohol nighttime - less than 0.2% alcohol two - 4 fl. oz. (118 ml) bottles (1 day, 1 night) homeopathic carton

Further Questions:

Questions? www.hylands.com or care@hylands.com


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.