Defend Cold And Mucus
Bryonia Alba Root, Euphrasia Stricta, Calcium Sulfide, Sodium Chloride, Phosphorus, Anemone Patens, Rumex Crispus Root, And Silicon Dioxide
Hyland's Inc.
Human Otc Drug
NDC 54973-3183Defend Cold And Mucus also known as Bryonia Alba Root, Euphrasia Stricta, Calcium Sulfide, Sodium Chloride, Phosphorus, Anemone Patens, Rumex Crispus Root, And Silicon Dioxide is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Defend Cold And Mucus is 54973-3183. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Defend Cold And Mucus drug includes Bryonia Alba Root - 6 [hp_X]/mL Calcium Sulfide - 12 [hp_X]/mL Euphrasia Stricta - 6 [hp_X]/mL Phosphorus - 30 [hp_X]/mL Pulsatilla Patens Whole - 6 [hp_X]/mL Rumex Crispus Root - 6 [hp_X]/mL Silicon Dioxide - 12 [hp_X]/mL Sodium Chloride - 30 [hp_X]/mL . The currest status of Defend Cold And Mucus drug is Active.
Drug Information:
| Drug NDC: | 54973-3183 |
| 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: | Defend 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: | Bryonia Alba Root, Euphrasia Stricta, Calcium Sulfide, Sodium Chloride, Phosphorus, Anemone Patens, Rumex Crispus Root, And Silicon Dioxide |
| 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: | Liquid |
| 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: | BRYONIA ALBA ROOT - 6 [hp_X]/mL
CALCIUM SULFIDE - 12 [hp_X]/mL
EUPHRASIA STRICTA - 6 [hp_X]/mL
PHOSPHORUS - 30 [hp_X]/mL
PULSATILLA PATENS WHOLE - 6 [hp_X]/mL
RUMEX CRISPUS ROOT - 6 [hp_X]/mL
SILICON DIOXIDE - 12 [hp_X]/mL
SODIUM CHLORIDE - 30 [hp_X]/mL
|
| 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 Jul, 2014 |
| 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. |
| UNII: | T7J046YI2B
1MBW07J51Q
C9642I91WL
27YLU75U4W
4M1169RWJD
9N1RM2S62C
ETJ7Z6XBU4
451W47IQ8X
|
| 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 |
|---|
| 54973-3183-1 | 1 BOTTLE, PLASTIC in 1 CARTON (54973-3183-1) / 118 mL in 1 BOTTLE, PLASTIC | 01 Jul, 2014 | 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 "hpus" indicates the active ingredients are in the official homeopathic pharmacopÅia of the united states. bryonia 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
Product Elements:
Defend cold and mucus bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone patens, rumex crispus root, and silicon dioxide citric acid monohydrate glycyrrhiza glabra water sodium benzoate glycerin bryonia alba root bryonia alba root euphrasia stricta euphrasia stricta calcium sulfide calcium sulfide sodium chloride chloride ion phosphorus phosphorus pulsatilla patens whole pulsatilla patens whole rumex crispus root rumex crispus root silicon dioxide silicon dioxide
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.
Warnings:
Warnings as with any drug, ask a doctor before use if pregnant or nursing. consult a physician if: symptoms persist for more than 7 days or worsen 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 a poison control center. do not use this product for persistent or chronic cough such as occurs with asthma, smoking or emphysema or if cough is accompanied by excessive phlegm (mucus). a persistent cough may be a sign of a serious condition. do not use if imprinted tamper band is broken or missing. in case of emergency, contact a medical professional or poison control center immediately. hyland's 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 nursing. consult a physician if: symptoms persist for more than 7 days or worsen 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 a poison control center. do not use this product for persistent or chronic cough such as occurs with asthma, smoking or emphysema or if cough is accompanied by excessive phlegm (mucus). a persistent cough may be a sign of a serious condition. do not use if imprinted tamper band is broken or missing. in case of emergency, contact a medical professional or poison control center immediately. hyland's 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 = millimeter, tsp = teaspoon adults and children 12 years and over 15 ml or 3 teaspoons 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) children 2 years to under 6 years 5 ml or 1 teaspoon up to 6 times per day (every 4 hours)
Package Label Principal Display Panel:
Principal display panel - 118 ml bottle carton ndc 54973-3183-1 homeopathic new! since 1903 hyland's ® defend⢠cold+ mucus* non-drowsy expectorant thins & loosens mucus in chest, throat and nose natural, safe & effective relief of: cough with mucus nasal & chest congestion dye free ⢠sugar free less than 0.1% alcohol 4 fl. oz. (118 ml) principal display panel - 118 ml bottle carton
Further Questions:
Questions or comments? (800) 624-9659