4 Kids Cold And Cough Day And Night Grape Flavor

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


Hyland's Inc.
Human Otc Drug
NDC 54973-3379
4 Kids Cold And Cough Day And Night Grape Flavor also known as Onion,anemone Pulsatilla, Phosphorus, Goldenseal, Calcium Sulfide, Sodium Chloride, Sulfur, Matricaria Chamomilla And Arabica Coffee Bean is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for 4 Kids Cold And Cough Day And Night Grape Flavor is 54973-3379. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4 Kids Cold And Cough Day And Night Grape Flavor drug includes . The currest status of 4 Kids Cold And Cough Day And Night Grape Flavor drug is Active.

Drug Information:

Drug NDC: 54973-3379
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: 4 Kids Cold And Cough Day And Night 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,anemone Pulsatilla, Phosphorus, Goldenseal, Calcium Sulfide, Sodium Chloride, Sulfur, Matricaria Chamomilla And Arabica Coffee Bean
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Hyland's 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: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: 01 Dec, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 08 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:Hyland's 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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
54973-3379-11 KIT in 1 CARTON (54973-3379-1) * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3243-1) / 118 mL in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3377-1) / 118 mL in 1 BOTTLE, PLASTIC01 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:

Relieves congestion, runny nose, sore throat, sneezing, cough, post nasal drip and occasional sleeplessness

Product Elements:

4 kids cold and cough day and night grape flavor onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean 4 kids cold n cough grape flavor onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur sodium benzoate citric acid monohydrate glycerin glycyrrhiza glabra water onion onion goldenseal goldenseal calcium sulfide calcium sulfide sodium chloride sodium cation phosphorus phosphorus anemone pulsatilla anemone pulsatilla sulfur sulfur 4 kids cold and cough nighttime natural grape flavor onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean citric acid monohydrate glycerin water glycyrrhiza glabra sodium benzoate anemone pulsatilla anemone pulsatilla sulfur sulfur calcium sulfide calcium sulfide goldenseal goldenseal sodium chloride chloride ion matricaria chamomilla matricaria chamomilla arabica coffee bean arabica coffee bean onion onion phosphorus phosphorus

Indications and Usage:

Uses ■ temporarily relieves symptoms of common cold in children, including: ■ runny nose ■ sore throat ■ sneezing ■ cough ■ post nasal drip ■ nasal or chest congestion

Uses ■ temporarily relieves symptoms of common cold in children at night, including: ■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ nasal or chest congestion ■ sore throat ■ occasional sleeplessness

Warnings:

Warnings 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. ask a doctor before use if you have: ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. a persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus). stop use and ask a doctor if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children.

Warnings 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. ask a doctor before use if you have: ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. a persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus). stop use and ask a doctor if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children.

Dosage and Administration:

Directions ■ use as directed. ■ do not refrigerate. ■ 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 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 ■ use as directed. ■ do not refrigerate. ■ 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 5 ml at bedtime and every 4 hours during the night until relieved. children 6 years to under 12 years 10 ml at bedtime and every 4 hours during the night until relieved. adults and children 12 years and over 15 ml at bedtime and every 4 hours during the night until relieved.

Stop Use:

Stop use and ask a doctor if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

Stop use and ask a doctor if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

Package Label Principal Display Panel:

Package label - kit carton hyland's naturals™ •kids• cold & cough combo pack no alcohol, sugar, parabens or dyes daytime congestion runny nose sore throat cough post nasal drip nighttime sleeplessness congestion runny nose sore throat cough post nasal drip 2-12 years natural grape flavor two - 4 fl. oz. (118 ml) bottles (1 day, 1 night) | total 8 fl. oz. (236 ml) homeopathic carton

Further Questions:

Questions? (800) 624-9659


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.