Childrens Cold And Cough Grape Flavor

Onion, Calcium Sulfide, Goldenseal, Sodium Chloride, Phosphorus, Anemone Pulsatilla, And Sulfur


Walgreen Company
Human Otc Drug
NDC 0363-9999
Childrens Cold And Cough Grape Flavor also known as Onion, Calcium Sulfide, Goldenseal, Sodium Chloride, Phosphorus, Anemone Pulsatilla, And Sulfur is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Childrens Cold And Cough Grape Flavor is 0363-9999. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Childrens Cold And Cough Grape Flavor drug includes Anemone Pulsatilla - 6 [hp_X]/mL Calcium Sulfide - 12 [hp_X]/mL Goldenseal - 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 Cold And Cough Grape Flavor drug is Active.

Drug Information:

Drug NDC: 0363-9999
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 Cold And Cough 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: Onion, Calcium Sulfide, Goldenseal, Sodium Chloride, Phosphorus, Anemone Pulsatilla, And Sulfur
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Walgreen Company
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
CALCIUM SULFIDE - 12 [hp_X]/mL
GOLDENSEAL - 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: 14 Dec, 2018
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:Walgreen Company
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
N0000175629
N0000184306
M0000728
M0006342
M0022575
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:I76KB35JEV
1MBW07J51Q
ZW3Z11D0JV
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]
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]
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]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Vegetable Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0363-9999-011 BOTTLE, PLASTIC in 1 CARTON (0363-9999-01) / 118 mL in 1 BOTTLE, PLASTIC14 Dec, 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:

Allium cepa 6x hpus................watery/runny nose, cold,hacking cough, painful throat 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

Product Elements:

Childrens cold and cough grape flavor onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur goldenseal goldenseal citric acid monohydrate sodium benzoate phosphorus phosphorus onion onion calcium sulfide calcium sulfide anemone pulsatilla anemone pulsatilla sulfur sulfur glycerin glycyrrhiza glabra water sodium chloride sodium cation

Indications and Usage:

Uses temporarily relieves the symptoms of the common cold, including: nasal or chest congestion,runny nose,sore throat,sneezing cough

Warnings:

Warnings as with any drug, ask a doctor before use if pregnant or breast-feeding. consult a physician if symptoms persist for more than 7 days or worsen. inflammation, fever or infection develops. symptoms are accompanied by a high fever (over 101°f). cough tends to recur or is accompanied by a 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 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 imprinted tamper-evident bottle cap 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:

Warnings as with any drug, ask a doctor before use if pregnant or breast-feeding. consult a physician if symptoms persist for more than 7 days or worsen. inflammation, fever or infection develops. symptoms are accompanied by a high fever (over 101°f). cough tends to recur or is accompanied by a 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 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 imprinted tamper-evident bottle cap 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.

Dosage and Administration:

Directions measure only with the dosing cup provided do not use dosing cup with other products on dosing cup, ml = milliliter children 2 years to under 6 years 5 ml up to 6 times per day (every 4 hours) children 6 years to under 12 years 10 ml up to 6 times per day (every 4 hours) adults and children 12 years and over 15 ml up to 6 times per day (every 4 hours)

Package Label Principal Display Panel:

Principal display panel-4 fl oz (118 ml) bottle carton walgreens compare to hyland’s 4 kids cold ’n cough natural grape flavor ndc 0363-9999-01 new children's homeopathic* dye-free cold & cough dye free alcohol free sugar free ages 2-12 years grape flavor 4 fl oz (118 ml) carton

Further Questions:

Questions or comments? 1-800-925-4733 distributed by: walgreen co. 200 wilmot rd., deerfield, il 60015 walgreens 100% satisfaction guaranteed walgreens.com ©2018 walgreen co.


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.