Childrens Nighttime Cold And Mucus
Onion, Bryonia Alba Root, Arabica Coffee Bean, Rumex Crispus Root, Goldenseal, Anemone Pulsatilla, Calcium Sulfide, Sulfur, Phosphorus, Matricaria Chamomilla, Euphrasia Stricta, Sodium Chloride And Silicon Dioxide
Wal-mart Stores, Inc
Human Otc Drug
NDC 49035-922Childrens Nighttime Cold And Mucus also known as Onion, Bryonia Alba Root, Arabica Coffee Bean, Rumex Crispus Root, Goldenseal, Anemone Pulsatilla, Calcium Sulfide, Sulfur, Phosphorus, Matricaria Chamomilla, Euphrasia Stricta, Sodium Chloride And Silicon Dioxide is a human otc drug labeled by 'Wal-mart Stores, Inc'. National Drug Code (NDC) number for Childrens Nighttime Cold And Mucus is 49035-922. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Childrens Nighttime Cold And Mucus 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 Childrens Nighttime Cold And Mucus drug is Active.
Drug Information:
| Drug NDC: | 49035-922 |
| 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 Mucus |
| 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, Bryonia Alba Root, Arabica Coffee Bean, Rumex Crispus Root, Goldenseal, Anemone Pulsatilla, Calcium Sulfide, Sulfur, Phosphorus, Matricaria Chamomilla, Euphrasia Stricta, Sodium Chloride And Silicon Dioxide |
| 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 - 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: | 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
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 |
|---|
| 49035-922-01 | 118 mL in 1 BOTTLE, PLASTIC (49035-922-01) | 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. |
Purpose:
Active ingredients purpose allium cepa 6x hpus runny nose with mucus, hacking cough, sore throat bryonia alba 6x hpus stubborn mucus in throat, cough with yellowish mucus chamomilla 3x hpus irritability, fussiness, occasional sleeplessness coffea cruda 3x hpus occasional sleeplessness, restlessness euphrasia officinalis 6x hpus cough with mucus in chest hepar sulph calc 12x hpus cough up mucus, mucus rattle with cough, stubborn mucus in chest hydrastis 6x hpus cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat natrum muriaticum 6x hpus accumulation of mucus in throat, cough up mucus phosphorus 30x hpus cough with expectoration of yellow mucus, chest congestion pulsatilla 6x hpus accumulation of mucus, discharge of thick yellowish mucus, loose cough rumex crispus 6x hpus runny nose, sneezing silicea 12x hpus nasal congestion sulphur 12x hpus cough with thick mucus, chest congestion, nasal congestion âhpusâ indicates that the active ingredients are in the official homeopathic pharmacopÅia of the united states.
Product Elements:
Childrens nighttime cold and mucus onion, bryonia alba root, arabica coffee bean, rumex crispus root, goldenseal, anemone pulsatilla, calcium sulfide, sulfur, phosphorus, matricaria chamomilla, euphrasia stricta, sodium chloride and silicon dioxide glycerin citric acid monohydrate water sodium benzoate licorice onion onion bryonia alba root bryonia alba root arabica coffee bean arabica coffee bean rumex crispus root rumex crispus root goldenseal goldenseal anemone pulsatilla anemone pulsatilla silicon dioxide silicon dioxide sulfur sulfur matricaria chamomilla matricaria chamomilla euphrasia stricta euphrasia stricta sodium chloride chloride ion calcium sulfide calcium sulfide phosphorus phosphorus
Indications and Usage:
Uses temporarily relieves the symptoms of the common cold in children especially at night including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and occasional sleeplessness.
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 high fever (101°f) ⢠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 persistent cough 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 imprinted
Read more...tamper band is broken or missing. in case of emergency 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 high fever (101°f) ⢠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 persistent cough 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 imprinted tamper band is broken or missing. in case of emergency in case of emergency, contact a medical professional or poison control center immediately.
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 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 49035-922-01 compare to hylandâs 4 kids cold ân mucus nighttime equate⢠less than 0.2% alcohol, sugar free, dye free homeopathic children's cold & mucus* nighttime ages 2 to 12 years for temporary relief of: mucus & congestion occasional sleeplessness runny nose cough 4 fl oz (118 ml) *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. label2 label1