4 Kids Cold And Mucus
Euphrasia Stricta,silicon Dioxide, Rumex Crispus Root, Anemone Pulsatilla, Goldenseal, Sodium Chloride, Phosphorus, Onion, Bryonia Alba Root, Matricaria Chamomilla, Arabica Coffee Bean, Calcium Sulfide And Sulfur
Hyland's Inc.
Human Otc Drug
NDC 54973-33814 Kids Cold And Mucus also known as Euphrasia Stricta,silicon Dioxide, Rumex Crispus Root, Anemone Pulsatilla, Goldenseal, Sodium Chloride, Phosphorus, Onion, Bryonia Alba Root, Matricaria Chamomilla, Arabica Coffee Bean, Calcium Sulfide And Sulfur is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for 4 Kids Cold And Mucus is 54973-3381. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in 4 Kids Cold And Mucus drug includes . The currest status of 4 Kids Cold And Mucus drug is Active.
Drug Information:
| Drug NDC: | 54973-3381 |
| 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 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: | Euphrasia Stricta,silicon Dioxide, Rumex Crispus Root, Anemone Pulsatilla, Goldenseal, Sodium Chloride, Phosphorus, Onion, Bryonia Alba Root, Matricaria Chamomilla, Arabica Coffee Bean, Calcium Sulfide And Sulfur |
| 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: | |
| 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 Aug, 2018 |
| 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: | 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. |
| UPC: | 0354973338111
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 54973-3381-1 | 1 KIT in 1 CARTON (54973-3381-1) * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3372-2) / 118 mL in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3179-1) / 118 mL in 1 BOTTLE, PLASTIC | 01 Aug, 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:
Bryonia alba 6x hpus...stubborn mucus in throat, cough with yellowish mucus 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 natrum muriaticum 30x 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
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
Product Elements:
4 kids cold and mucus euphrasia stricta,silicon dioxide, rumex crispus root, anemone pulsatilla, goldenseal, sodium chloride, phosphorus, onion, bryonia alba root, matricaria chamomilla, arabica coffee bean, calcium sulfide and sulfur 4 kids cold and mucus nighttime euphrasia stricta,silicon dioxide, rumex crispus root, anemone pulsatilla, goldenseal, sodium chloride, phosphorus, onion, bryonia alba root, matricaria chamomilla, arabica coffee bean, calcium sulfide and sulfur glycyrrhiza glabra sodium benzoate water citric acid monohydrate glycerin matricaria chamomilla matricaria chamomilla sodium chloride chloride ion sulfur sulfur rumex crispus root rumex crispus root onion onion bryonia alba root bryonia alba root euphrasia stricta euphrasia stricta goldenseal goldenseal phosphorus phosphorus arabica coffee bean arabica coffee bean calcium sulfide calcium sulfide silicon dioxide silicon dioxide anemone pulsatilla anemone pulsatilla 4 kids complete cold and mucus bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide sodium benzoate glycerin water citric acid monohydrate glycyrrhiza glabra euphrasia stricta euphrasia stricta bryonia alba root bryonia alba root anemone pulsatilla anemone pulsatilla sodium chloride chloride ion phosphorus phosphorus silicon dioxide silicon dioxide rumex crispus root rumex crispus root calcium sulfide calcium sulfide
Indications and Usage:
Uses temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.
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 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. 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. 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. do not use if imprinted tamper-evident bottle band is broken or missing. the
Read more...inner packaged bottle is child-resistant. in case of emergency, contact a medical professional or poison control center immediately. hylandâs may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
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. 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. 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. do not use if imprinted tamper-evident bottle band is broken or missing. the
Read more...inner packaged bottle is child-resistant. in case of emergency, contact a medical professional or poison control center immediately. hylandâs may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
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. 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. 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. do not use if imprinted tamper-evident bottle band is broken or missing. the inner packaged bottle is child-resistant. in case of emergency, contact a medical professional or poison control center immediately. hylandâs may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
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. 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. 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. do not use if imprinted tamper-evident bottle band is broken or missing. the inner packaged bottle is child-resistant. in case of emergency, contact a medical professional or poison control center immediately. hylandâs may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
Dosage and Administration:
Directions measure only with the dosing cup provided do not use dosing cup with other products on dosing cup, ml = milliliter, tsp = teaspoon children 2 years to under 6 years 5 ml or 1 teaspoon up to 6 times per day (every 4 hours) children 6 years to under 12 years 10 ml or 2 teaspoons up to 6 times per day (every 4 hours) adults and children 12 years and over 15 ml or 3 teaspoons up to 6 times per day (every 4 hours)
Directions measure only with the dosing cup provided do not use dosing cup with other products 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 - kit carton ndc 54973-3381-1 homeopathic ages 2-12 natural relief since 1903 hyland's 4 kids cold'n mucus* loosens mucus in chest, throat and nose day & night value pack daytime mucus & congestion runny nose cough alcohol free sugar free dye free 4 fl. oz. (118 ml) daytime nighttime mucus & congestion occasional sleeplessness runny nose cough less than 0.2% alcohol sugar free dye free 4 fl. oz. (118 ml) nighttime 8 fl. oz. (236 ml) total kit carton
Further Questions:
Questions or comments? (800) 624-9659