Childrens Cold And Cough Day And Night Value Pack
Onion, Calcium Sulfide, Sodium Chloride, Anemone Pulsatilla, Arabica Coffee Bean, Matricaria Chamomilla, Sulfur, Phosphorus And Goldenseal
Walgreen Company
Human Otc Drug
NDC 0363-9998Childrens Cold And Cough Day And Night Value Pack also known as Onion, Calcium Sulfide, Sodium Chloride, Anemone Pulsatilla, Arabica Coffee Bean, Matricaria Chamomilla, Sulfur, Phosphorus And Goldenseal is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Childrens Cold And Cough Day And Night Value Pack is 0363-9998. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Childrens Cold And Cough Day And Night Value Pack drug includes . The currest status of Childrens Cold And Cough Day And Night Value Pack drug is Active.
Drug Information:
| Drug NDC: | 0363-9998 |
| 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 Value 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, Calcium Sulfide, Sodium Chloride, Anemone Pulsatilla, Arabica Coffee Bean, Matricaria Chamomilla, Sulfur, Phosphorus And Goldenseal |
| 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: | 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 Feb, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 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. |
| 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 |
|---|
| 0363-9998-01 | 1 KIT in 1 CARTON (0363-9998-01) * 118 mL in 1 BOTTLE, PLASTIC (0363-9997-01) * 118 mL in 1 BOTTLE, PLASTIC (0363-9996-01) | 01 Feb, 2019 | 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:
Purpose temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal or chest congestion or sore throat with accompanying occasional sleeplessness.
Product Elements:
Childrens cold and cough day and night value pack onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal childrens cold and cough onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal water glycerin citric acid monohydrate sodium benzoate glycyrrhiza glabra sodium chloride sodium cation calcium sulfide calcium sulfide sulfur sulfur phosphorus phosphorus goldenseal goldenseal onion onion anemone pulsatilla anemone pulsatilla childrens cold and cough nighttime onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal sodium benzoate glycyrrhiza glabra glycerin water citric acid monohydrate arabica coffee bean arabica coffee bean onion onion calcium sulfide calcium sulfide phosphorus phosphorus sodium chloride chloride ion anemone pulsatilla anemone pulsatilla matricaria chamomilla matricaria chamomilla goldenseal goldenseal sulfur sulfur
Indications and Usage:
Uses temporarily relieves the symptoms of the common cold including nasal or chest congestion, runny nose, sore throat, sneezing or cough.
Uses temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal or chest congestion or 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 â inflammation, fever or infection develops â symptoms are accompanied by a fever â cough tends to recur or is accompanied by a 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 medical professional. 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. in case of emergency 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 â symptoms persist for more than 7 days or worsen â inflammation, fever or infection develops â symptoms are accompanied by a fever â cough tends to recur or is accompanied by a 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 medical professional. a persistent cough may be a sign of a serious condition. 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. in case of emergency contact a medical professional or poison control cent
Read more...er immediately.
Do Not Use:
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 â inflammation, fever or infection develops â symptoms are accompanied by a fever â cough tends to recur or is accompanied by a 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 medical professional. 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. in case of emergency 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 â symptoms persist for more than 7 days or worsen â inflammation, fever or infection develops â symptoms are accompanied by a fever â cough tends to recur or is accompanied by a 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 medical professional. a persistent cough may be a sign of a serious condition. 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. in case of emergency contact a medical professional or poison control center immediately.
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 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)
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 or as necessary children 6 years to under 12 years 10 ml at bedtime and every 4 hours during the night or as necessary adults and children 12 years and over 15 ml at bedtime and every 4 hours during the night or as necessary
Package Label Principal Display Panel:
Principal display panel day & night pack ndc 0363-9998-01 walgreens compare to hyland's 4 kids cold & cough day & night value pack walgreens pharmacist recommended daytime children's dye-free cold & cough sugar free alcohol free ⢠homeopathic flavor free 4 fl oz (118 ml) daytime nighttime children's dye-free cold & cough sugar free alcohol free ⢠homeopathic flavor free 4 fl oz (118 ml) nighttime 8 fl oz (236 ml) total ages 2-12 years *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. carton
Further Questions:
Walgreens.com 1-800-925-4733