Kids Cough And Mucus Nighttime Grape Flavor

Rumex Crispus Root, Antimony Potassium Tartrate, Bryonia Alba Root, Matricaria Chamomilla Whole, Pulsatilla Vulgaris, Calcium Sulfide, Ipecac, Goldenseal, Phosphorus, Ferrosoferric Phosphate

Hyland's Consumer Health Inc.
Human Otc Drug
NDC 54973-4057

Kids Cough And Mucus Nighttime Grape Flavor also known as Rumex Crispus Root, Antimony Potassium Tartrate, Bryonia Alba Root, Matricaria Chamomilla Whole, Pulsatilla Vulgaris, Calcium Sulfide, Ipecac, Goldenseal, Phosphorus, Ferrosoferric Phosphate is a human otc drug labeled by 'Hyland's Consumer Health Inc.'. National Drug Code (NDC) number for Kids Cough And Mucus Nighttime Grape Flavor is 54973-4057. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Kids Cough And Mucus Nighttime Grape Flavor drug includes Antimony Potassium Tartrate - 15 [hp_X]/mL Bryonia Alba Root - 15 [hp_X]/mL Calcium Sulfide - 12 [hp_X]/mL Ferrosoferric Phosphate - 12 [hp_X]/mL Goldenseal - 15 [hp_X]/mL Ipecac - 12 [hp_X]/mL Matricaria Chamomilla Whole - 6 [hp_X]/mL Phosphorus - 15 [hp_X]/mL Pulsatilla Vulgaris - 12 [hp_X]/mL Rumex Crispus Root - 6 [hp_X]/mL . The currest status of Kids Cough And Mucus Nighttime Grape Flavor drug is Active.

Drug Information:

Drug NDC:	54973-4057
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:	Kids Cough And Mucus Nighttime Grape Flavor
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:	Rumex Crispus Root, Antimony Potassium Tartrate, Bryonia Alba Root, Matricaria Chamomilla Whole, Pulsatilla Vulgaris, Calcium Sulfide, Ipecac, Goldenseal, Phosphorus, Ferrosoferric Phosphate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Hyland's Consumer Health 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:	ANTIMONY POTASSIUM TARTRATE - 15 [hp_X]/mL BRYONIA ALBA ROOT - 15 [hp_X]/mL CALCIUM SULFIDE - 12 [hp_X]/mL FERROSOFERRIC PHOSPHATE - 12 [hp_X]/mL GOLDENSEAL - 15 [hp_X]/mL IPECAC - 12 [hp_X]/mL MATRICARIA CHAMOMILLA WHOLE - 6 [hp_X]/mL PHOSPHORUS - 15 [hp_X]/mL PULSATILLA VULGARIS - 12 [hp_X]/mL RUMEX CRISPUS ROOT - 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 Mar, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	05 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 Consumer Health 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:	DL6OZ476V3 T7J046YI2B 1MBW07J51Q 91GQH8I5F7 ZW3Z11D0JV 62I3C8233L G0R4UBI2ZZ 27YLU75U4W I76KB35JEV 9N1RM2S62C
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
54973-4057-1	1 BOTTLE, PLASTIC in 1 CARTON (54973-4057-1) / 118 mL in 1 BOTTLE, PLASTIC	01 Mar, 2022	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

Kids Cough And Mucus Day And Night Grape

Rumex Crispus Root & more..

Kit
Hyland's Inc.
NDC: 54973-4059

Kids Cough And Mucus Nighttime Grape Flavor

Rumex Crispus Root & more..

Liquid
Hyland's Consumer Health Inc.
NDC: 54973-4057

Purpose:

Temporarily relieves symptoms of common cold in children at night, including cough, runny nose, sneezing, sore throat, chest or nasal congestion, mucus in chest or throat, occasional sleeplessness

Product Elements:

Kids cough and mucus nighttime grape flavor rumex crispus root, antimony potassium tartrate, bryonia alba root, matricaria chamomilla whole, pulsatilla vulgaris, calcium sulfide, ipecac, goldenseal, phosphorus, ferrosoferric phosphate water rumex crispus root rumex crispus root ipecac ipecac sodium benzoate antimony potassium tartrate antimony cation (3+) bryonia alba root bryonia alba root matricaria chamomilla whole matricaria chamomilla whole glycyrrhiza glabra citric acid monohydrate glycerin ferrosoferric phosphate ferrosoferric phosphate calcium sulfide calcium sulfide pulsatilla vulgaris pulsatilla vulgaris goldenseal goldenseal phosphorus phosphorus natural grape flavor

Indications and Usage:

Uses temporarily relieves symptoms of common cold in children at night, including: â cough â runny nose â sneezing â sore throat â chest or nasal congestion â mucus in chest or throat 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 smoking, 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 7 days 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. if pregnant or breastfeeding ask a health professional before use. 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 cup provided. â do not use dosing cup with other products. â on dosing cup, ml = milliliter. children 2 years to under 6 years 5 ml at bedtime and every 4 hours during the night until relieved. children 6 years to under 12 years 10 ml at bedtime and every 4 hours during the night until relieved. adults and children 12 years and over 15 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 7 days 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 naturalsâ¢ â¢kidsâ¢ cough & mucus* nighttime no alcohol, sugar, parabens or dyes sleeplessness cough mucus congestion runny nose effective mucus relief 2-12 years natural grape flavor 4 fl. oz. (118 ml) 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.