NDC 71971-9066 Kids Relief

Pulsatilla, Allium Cepa, Arsenicum Album, Nux Vomica, Euphrasia Offinalis, Sabadilla, Aralia Racemosa, Cuprum Metallicum

NDC Product Code 71971-9066

NDC Code: 71971-9066

Proprietary Name: Kids Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Pulsatilla, Allium Cepa, Arsenicum Album, Nux Vomica, Euphrasia Offinalis, Sabadilla, Aralia Racemosa, Cuprum Metallicum What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 71971 - Homeolab International (canada) Inc
    • 71971-9066 - Kids Relief

NDC 71971-9066-8

Package Description: 1 BOTTLE in 1 CARTON > 25 mL in 1 BOTTLE

NDC Product Information

Kids Relief with NDC 71971-9066 is a a human over the counter drug product labeled by Homeolab International (canada) Inc. The generic name of Kids Relief is pulsatilla, allium cepa, arsenicum album, nux vomica, euphrasia offinalis, sabadilla, aralia racemosa, cuprum metallicum. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Homeolab International (canada) Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Kids Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ANEMONE PULSATILLA 8 [hp_X]/25mL
  • ONION 6 [hp_X]/25mL
  • ARSENIC TRIOXIDE 8 [hp_X]/25mL
  • STRYCHNOS NUX-VOMICA SEED 6 [hp_X]/25mL
  • EUPHRASIA STRICTA 6 [hp_X]/25mL
  • SCHOENOCAULON OFFICINALE SEED 6 [hp_X]/25mL
  • ARALIA RACEMOSA ROOT 6 [hp_X]/25mL
  • COPPER 8 [hp_X]/25mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CITRIC ACID ACETATE (UNII: DSO12WL7AU)
  • RASPBERRY (UNII: 4N14V5R27W)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Homeolab International (canada) Inc
Labeler Code: 71971
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 07-26-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Kids Relief Product Label Images

Kids Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active Ingredients HPUS:Pulsatilla 8X   (Wind flower)Allium cepa 6X (Onion)Arsenicum album 8X   (Arsenous oxide)Nux Vomica 6X   (Poison nut)Euphrasia officinalis 6X   (Eyebright)Sabadilla 6X (Cevadilla)Aralia racemosa 6X (Spikenard)Cuprum metallicum 8X   (Metallic copper)

Otc - Purpose

PurposeSinus symptoms, sneezing, nasal congestion, runny nose, itchy eyes, nose and throat, watery eyes headache, throat irritation.The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated

Indications & Usage

UsesThis homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by sinus symptoms*:• sneezing• nasal congestion• runny nose• itchy eyes, nose and throat• watery eyes• headache• throat irritation

Warnings

WarningsDo not use if seal is broken or missing.Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 3 days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

DirectionsChildren under 6 months of age: Consult a licensed healthcare practitioner before using this product.Children 6 months to 9 years old: 0.5 ml orally every 8 hours or 3 times a day.Children 2 to 9 years old: 0.75 ml orally every 8 hours or 3 times a day.Reduce intake with improvements.In acute phase only:Children 2 to 9 years old; Give 1 dropper (0.75ml) at the onset of symptoms. Repeat two more times at intervals of 15 minutes.Repeat this procedure up to 6 times per day if symptoms reoccur, or as directed by a healthcare practitioner.Not to be taken with meals

Storage And Handling

Other information•Store at room temperature

Inactive Ingredient

Inactive IngredientsPurified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, raspberry flavour.

* Please review the disclaimer below.

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