Kids Relief Cough And Cold Syrup Combo Pack Daytime Formula And Nighttime Formula
Drosera Rotundifolia Flowering Top, Arnica Montana, Bryonia Alba Whole, Ipecacuanha, Cetraria Islandica Subsp. Islandica, Cochineal, Corallium Rubrum Whole, Stannum Metallicum, Chamomilla, Coffea Cruda
Homeolab International (canada) Inc
Human Otc Drug
NDC 71971-6105Kids Relief Cough And Cold Syrup Combo Pack Daytime Formula And Nighttime Formula also known as Drosera Rotundifolia Flowering Top, Arnica Montana, Bryonia Alba Whole, Ipecacuanha, Cetraria Islandica Subsp. Islandica, Cochineal, Corallium Rubrum Whole, Stannum Metallicum, Chamomilla, Coffea Cruda is a human otc drug labeled by 'Homeolab International (canada) Inc'. National Drug Code (NDC) number for Kids Relief Cough And Cold Syrup Combo Pack Daytime Formula And Nighttime Formula is 71971-6105. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Kids Relief Cough And Cold Syrup Combo Pack Daytime Formula And Nighttime Formula drug includes . The currest status of Kids Relief Cough And Cold Syrup Combo Pack Daytime Formula And Nighttime Formula drug is Active.
Drug Information:
| Drug NDC: | 71971-6105 |
| 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 Relief Cough And Cold Syrup Combo Pack Daytime Formula And Nighttime Formula |
| 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: | Drosera Rotundifolia Flowering Top, Arnica Montana, Bryonia Alba Whole, Ipecacuanha, Cetraria Islandica Subsp. Islandica, Cochineal, Corallium Rubrum Whole, Stannum Metallicum, Chamomilla, Coffea Cruda |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Homeolab International (canada) 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 Sep, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| 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, 2024 |
| 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: | Homeolab International (Canada) 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 |
|---|
| 71971-6105-7 | 1 KIT in 1 KIT (71971-6105-7) * 1 BOTTLE in 1 CARTON (71971-9121-5) / 100 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (71971-9151-5) / 100 mL in 1 BOTTLE | 01 Sep, 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:
Purpose part 1 - cough cold daytime syrup drosera rotundifolia flowering top dry cough arnica montana aches and pain , chest congestion bryonia alba whole painful cough ipecacuanha (ipecac) night cough cetraria islandica subsp. islandica cough with expectoration cochineal (coccus cacti) cough with expectoration corallium rubrum whole painful cough stannum metallicum (tin) cough, chills and lessen mucus part 2 - cough cold nighttime syrup drosera rotundifolia flowering top dry cough arnica montana aches and pain , chest congestion bryonia alba whole painful cough cetraria islandica subsp. islandica cough with expectoration cochineal (coccus cacti) cough with expectoration corallium rubrum whole painful cough stannum metallicum (tin) cough, chills and lessen mucus chamomilla (german chamomille) restlessness, irritability and nocturnal awakening coffea cruda (coffee) restlessness and sleeplessness the letters 'hpus' indicate that the components in this product are officially monographed in the homoeopathic pharmacopoeia of the united states.
Product Elements:
Kids relief cough and cold syrup combo pack daytime formula and nighttime formula drosera rotundifolia flowering top, arnica montana, bryonia alba whole, ipecacuanha, cetraria islandica subsp. islandica, cochineal, corallium rubrum whole, stannum metallicum, chamomilla, coffea cruda kids relief drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum water caramel sorbitol sodium benzoate potassium sorbate citric acid monohydrate drosera rotundifolia flowering top drosera rotundifolia flowering top arnica montana arnica montana bryonia alba whole bryonia alba whole ipecac ipecac cetraria islandica whole cetraria islandica whole cochineal cochineal corallium rubrum whole corallium rubrum whole tin tin kids relief drosera, arnica montana, bryonia, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum, chamomilla, coffee crudea water sorbitol caramel sodium benzoate potassium sorbate citric acid monohydrate drosera rotundifolia flowering top drosera rotundifolia flowering top arnica montana arnica montana bryonia alba whole bryonia alba whole cetraria islandica whole cetraria islandica whole protortonia cacti protortonia cacti tin tin chamomile chamomile arabica coffee bean arabica coffee bean corallium rubrum whole corallium rubrum whole
Indications and Usage:
Uses t his ho meo pathic medicine is made from a combination of ingredients traditionally used to help symptoms associated with nighttime cough and cold*; dry cough, cough with expectorantion, chest congestion, aches and pain,fever. *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.
Warnings:
Warnings stop use and ask a doctor if: ⢠pain & cough get worse or last more than 5 days (children) or 7 days (adults). ⢠fever gets worse or lasts more than 3 days. ⢠redness or swelling is present. ⢠new symptoms occur. ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. keep out of reach of children. in case of accidental overdose, contact a medical professional or poison control center immediately.
Dosage and Administration:
Directions part 1 kids relief daytime syrup children under 6 months of age: consult a licensed healthcare practitioner before using the product. children 6 months to 2 years old: 2.5 ml or ½ teaspoon, every 6 hours or 4 times a day. children 2 to 12 years old: 5 ml or 1 teaspoon, every 6 hours or 4 times a day. part 2 kids relief nighttime syrup children under 6 months of age: consult a licensed healthcare practitioner before using the product. children 6 months to 2 years old: 2.5 ml or ½ teaspoon, every 8 hours or 3 times a day. children 2 to 12 years old: 5 ml or 1 teaspoon, every 8 hours or 3 times a day.
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