Kids Cold And Cough Combo Pack
Onion, Chamomile, Arabica Coffee Bean, Calcium Sulfide, Golden Seal, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris Top, Sulfur
Hyland's Consumer Health Inc.
Human Otc Drug
NDC 54973-4112Kids Cold And Cough Combo Pack also known as Onion, Chamomile, Arabica Coffee Bean, Calcium Sulfide, Golden Seal, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris Top, Sulfur is a human otc drug labeled by 'Hyland's Consumer Health Inc.'. National Drug Code (NDC) number for Kids Cold And Cough Combo Pack is 54973-4112. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Kids Cold And Cough Combo Pack drug includes . The currest status of Kids Cold And Cough Combo Pack drug is Active.
Drug Information:
| Drug NDC: | 54973-4112 |
| 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: | Kids Cold And Cough Combo 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, Chamomile, Arabica Coffee Bean, Calcium Sulfide, Golden Seal, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris Top, Sulfur |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hyland's Consumer Health 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, 2022 |
| 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: | Hyland's Consumer Health 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 |
|---|
| 54973-4112-1 | 1 KIT in 1 KIT (54973-4112-1) * 1 BOTTLE, PLASTIC in 1 CARTON (54973-4111-1) / 118 mL in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 CARTON (54973-4110-1) / 118 mL in 1 BOTTLE, PLASTIC | 01 Dec, 2022 | 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:
Sleeplessness, congestion, runny nose, sore throat, cough, post nasal drip
Product Elements:
Kids cold and cough combo pack onion, chamomile, arabica coffee bean, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris top, sulfur kids cold and cough nighttime grape flavor onion, chamomile, arabica coffee bean, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris top, sulfur calcium sulfide calcium sulfide goldenseal goldenseal chamomile chamomile sodium chloride chloride ion sulfur sulfur arabica coffee bean arabica coffee bean pulsatilla vulgaris top pulsatilla vulgaris top phosphorus phosphorus onion onion glycerin water citric acid monohydrate sodium benzoate glycyrrhiza glabra natural grape flavor kids cold and cough daytime grape flavor onion, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris whole, sulfur goldenseal goldenseal sodium chloride chloride ion phosphorus phosphorus glycyrrhiza glabra onion onion pulsatilla vulgaris whole pulsatilla vulgaris whole citric acid monohydrate water calcium sulfide calcium sulfide sulfur sulfur glycerin sodium benzoate natural grape flavor
Indications and Usage:
Uses â helps temporarily relieve symptoms of common cold in children, including: â runny nose â sore throat â sneezing â cough â post nasal drip â nasal or chest congestion
Uses â helps temporarily relieve symptoms of common cold in children at night, including: â cough â runny nose â post nasal drip â sneezing â sore throat â nasal or chest congestion â 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 â persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. a persistent cough may be a sign of a serious condition. â cough that is accompanied by excessive phlegm (mucus). stop use and ask a doctor if â symptoms persist for more than 7 days or worsen. â inflammation, fever or infection is present or develops. â 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 â persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. a persistent cough may be a sign of a serious condition. â cough that is accompanied by excessive phlegm (mucus). stop use and ask a doctor if â symptoms persist for more than 7 days or worsen. â inflammation, fever or infection is present or develops. â 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 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 4 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 4 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 â symptoms persist for more than 7 days or worsen. â inflammation, fever or infection is present or develops. â cough tends to recur or is accompanied by a fever, rash or persistent headache.
Stop use and ask a doctor if â symptoms persist for more than 7 days or worsen. â inflammation, fever or infection is present or develops. â cough tends to recur or is accompanied by a fever, rash or persistent headache.
Package Label Principal Display Panel:
Principal display panel hyland's naturals⢠cold & cough combo pack no alcohol, sugar, parabens or dyes daytime nighttime congestion sleeplessness runny nose congestion sore throat runny nose cough sore throat post nasal drip cough post nasal drip 4 - 12 years natural grape flavor two - 4 fl. oz. (118 ml) bottles (1 day, 1 night) homeopathic carton
Further Questions:
Questions? www.hylands.com or care@hylands.com