Childrens Nighttime Cold And Cough

Onion, Arabica Coffee Bean, Calcium Sulfide, Phosphorus, Matricaria Chamomilla, Anemone Pulsatilla, Goldenseal, Sulfur And Sodium Chloride

Wal-mart Stores, Inc
Human Otc Drug
NDC 49035-920

Childrens Nighttime Cold And Cough also known as Onion, Arabica Coffee Bean, Calcium Sulfide, Phosphorus, Matricaria Chamomilla, Anemone Pulsatilla, Goldenseal, Sulfur And Sodium Chloride is a human otc drug labeled by 'Wal-mart Stores, Inc'. National Drug Code (NDC) number for Childrens Nighttime Cold And Cough is 49035-920. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Childrens Nighttime Cold And Cough drug includes Anemone Pulsatilla - 6 [hp_X]/mL Arabica Coffee Bean - 6 [hp_X]/mL Calcium Sulfide - 12 [hp_X]/mL Goldenseal - 6 [hp_X]/mL Matricaria Chamomilla - 6 [hp_X]/mL Onion - 6 [hp_X]/mL Phosphorus - 12 [hp_X]/mL Sodium Chloride - 6 [hp_X]/mL Sulfur - 12 [hp_X]/mL . The currest status of Childrens Nighttime Cold And Cough drug is Active.

Drug Information:

Drug NDC:	49035-920
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:	Childrens Nighttime Cold And Cough
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:	Onion, Arabica Coffee Bean, Calcium Sulfide, Phosphorus, Matricaria Chamomilla, Anemone Pulsatilla, Goldenseal, Sulfur And Sodium Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Wal-mart Stores, 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 - 6 [hp_X]/mL CALCIUM SULFIDE - 12 [hp_X]/mL GOLDENSEAL - 6 [hp_X]/mL MATRICARIA CHAMOMILLA - 6 [hp_X]/mL ONION - 6 [hp_X]/mL PHOSPHORUS - 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:	02 Jul, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 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:	Wal-Mart Stores, 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 1MBW07J51Q ZW3Z11D0JV G0R4UBI2ZZ 492225Q21H 27YLU75U4W 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] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [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
49035-920-01	118 mL in 1 BOTTLE, PLASTIC (49035-920-01)	02 Jul, 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

Childrens Nighttime Cold And Cough

Onion & more..

Liquid
Wal-Mart Stores, Inc
NDC: 49035-920

Purpose:

Active ingredients purpose allium cepa 6x hpus watery/runny nose, cold, hacking cough, sore throat chamomilla 6x hpus sensitive, irritable, fussy, nocturnal occasional sleeplessness coffea cruda 6x hpus occasional sleeplessness, restlessness hepar sulph calc 12x hpus cold, sneezing hydrastis 6x hpus rattling/tickling cough, sinus congestion dry/raw/sore throat natrum muriaticum 6x hpus dry cough, sore throat phosphorus 12x hpus hoarse/dry cough, nasal congestion, chest congestion pulsatilla 6x hpus moist cough, cold, nasal congestion sulphur 12x hpus chest congestion, nasal congestion, sneezing, runny nose âhpusâ indicates that the active ingredients are in the official homeopathic pharmacopÅia of the united states.

Product Elements:

Childrens nighttime cold and cough onion, arabica coffee bean, calcium sulfide, phosphorus, matricaria chamomilla, anemone pulsatilla, goldenseal, sulfur and sodium chloride citric acid monohydrate sodium benzoate glycerin glycyrrhiza glabra water onion onion arabica coffee bean arabica coffee bean calcium sulfide calcium sulfide phosphorus phosphorus sulfur sulfur goldenseal goldenseal anemone pulsatilla anemone pulsatilla matricaria chamomilla matricaria chamomilla sodium chloride sodium cation

Indications and Usage:

Uses temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal and chest congestion, and sore throat with accompanying occasional sleeplessness.

Warnings:

Warnings as with any drug, ask a doctor before use if pregnant or breast-feeding. consult a physician if: â¢ symptoms persist for more than 7 days or worsen ï®â¢ inflammation, fever or infection develops ï® â¢ symptoms are accompanied by high fever (101Â°f) ï® â¢ cough tends to recur or is accompanied by high fever, rash or persistent headache keep this and all medications out of the reach of children. in case of accidental overdose, contact a medical professional or poison control center immediately. do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional. a persistent cough may be a sign of a serious condition. sore throat warning sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. consult a doctor promptly. do not use if imprin Read more...

ted tamper-evident bottle band is broken or missing. the inner packaged bottle is child-resistant. in case of emergency, contact a medical professional or poison control center immediately.

Do Not Use:

Dosage and Administration:

Directions ï® measure only with the dosing cup provided ï® do not use dosing cup with other products ï® on dosing cup, ml = milliliter, tsp = teaspoon children 2 years to under 6 years 5 ml or 1 teaspoon at bedtime and every 4 hours during the night or as necessary children 6 years ery to under 12 years 10 ml or 2 teaspoons at bedtime and every 4 hours during the night or as necessary adults and children 12 years and over 15 ml or 3 teaspoons at bedtime and every 4 hours during the night or as necessary

Package Label Principal Display Panel:

Principal display panel - 118 ml bottle label ndc 49035-920-01 compare to hyland's 4 kids cold 'n cough nighttime equateâ¢ alcohol free, sugar free, dye free homeopathic childrens cold & cough* nighttime ages 2 to 12 years for temporary relief of: chest congestion occasional sleeplessness runny nose sore throat cough 4 fl oz (118ml) *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. label label2

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.