Childrens Cold And Cough Day And Night Twin Pack
Onion,matricaria Chamomilla,arabica Coffee Bean,calcium Sulfide,goldenseal,sodium Chloride,phosphorus,anemone Pulsatilla And Sulfur
Wal-mart Stores, Inc
Human Otc Drug
NDC 49035-925Childrens Cold And Cough Day And Night Twin Pack also known as Onion,matricaria Chamomilla,arabica Coffee Bean,calcium Sulfide,goldenseal,sodium Chloride,phosphorus,anemone Pulsatilla And Sulfur is a human otc drug labeled by 'Wal-mart Stores, Inc'. National Drug Code (NDC) number for Childrens Cold And Cough Day And Night Twin Pack is 49035-925. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Childrens Cold And Cough Day And Night Twin Pack drug includes . The currest status of Childrens Cold And Cough Day And Night Twin Pack drug is Active.
Drug Information:
| Drug NDC: | 49035-925 |
| 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 Day And Night Twin Pack |
| 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,matricaria Chamomilla,arabica Coffee Bean,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: | Wal-mart Stores, 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 Jul, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | 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. |
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 49035-925-01 | 1 KIT in 1 CARTON (49035-925-01) * 118 mL in 1 BOTTLE, PLASTIC (49035-920-01) * 1 BOTTLE, PLASTIC in 1 CARTON (49035-927-01) / 118 mL in 1 BOTTLE, PLASTIC | 01 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 watery/runny nose, cold, hacking cough, sore 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 âhpusâ indicates that the active ingredients are in the official homeopathic pharmacopÅia of the united states.
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 cold and cough day and night twin pack onion,matricaria chamomilla,arabica coffee bean,calcium sulfide,goldenseal,sodium chloride,phosphorus,anemone pulsatilla and sulfur childrens nighttime cold and cough onion, arabica coffee bean, calcium sulfide, phosphorus, matricaria chamomilla, anemone pulsatilla, goldenseal, sulfur and sodium chloride citric acid monohydrate glycerin sodium benzoate glycyrrhiza glabra water onion onion arabica coffee bean arabica coffee bean calcium sulfide calcium sulfide phosphorus phosphorus anemone pulsatilla anemone pulsatilla sodium chloride sodium cation matricaria chamomilla matricaria chamomilla sulfur sulfur goldenseal goldenseal cold and cough onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal glycyrrhiza glabra citric acid monohydrate water glycerin sodium benzoate phosphorus phosphorus anemone pulsatilla anemone pulsatilla goldenseal goldenseal sodium chloride sodium cation sulfur sulfur onion onion calcium sulfide calcium sulfide
Indications and Usage:
Uses temporarily relieves the symptoms of the common cold including nasal and chest congestion, runny nose, sore throat, sneezing and cough.
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: 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. 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 medical 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. in case of emergency or accidental overdose, contact a medical professional or poison control center immediately.
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 ï®
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. 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 medical 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. in case of emergency or accidental overdose, contact a medical professional or poison control center immediately.
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 ï®
Dosage and Administration:
Directions shake well before using. measure only with the dosing cup provided. do not use dosing cup with other products. on dosing cup, ml = milliliter.
Directions shake well before using. 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 5ml at bedtime and every 4 hours during the night or as necessary children 6 years to under 12 years 10ml at bedtime and every 4 hours during the night or as necessary adults and children 12 years and over 15ml at bedtime and every 4 hours during the night or as necessary
Package Label Principal Display Panel:
Primary principal display panel - children's cold & cough day & night value pack value pack ndc 49035-95-01 equate⢠compare to hylandâs 4 kids cold ân cough day & night value pack active ingredients children's alcohol-free, sugar-free dye-free homeopathic cold & cough* daytime ages 2 to12 years for temporary relief of: nasal congestion runny nose sore throat sneezing cough *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. 4 fl oz (118ml) daytime 8 fl oz (236ml) total children's alcohol-free, sugar-free dye-free homeopathic cold & cough* nighttime ages 2 to12 years for temporary relief of: chest congestion occasional sleeplessness runny nose sore throat sneezing cough *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. 4 fl oz (118ml) nighttime carton value pack