NDC 71971-9121 Kids Relief

Drosera, Arnica Montana, Bryonia, Ipecacuanha, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum

NDC Product Code 71971-9121

NDC CODE: 71971-9121

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: Drosera, Arnica Montana, Bryonia, Ipecacuanha, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum 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

NDC 71971-9121-4

Package Description: 30 mL in 1 BOTTLE

NDC 71971-9121-5

Package Description: 1 BOTTLE in 1 CARTON > 100 mL in 1 BOTTLE

NDC 71971-9121-9

Package Description: 1 BOTTLE in 1 CARTON > 250 mL in 1 BOTTLE

NDC Product Information

Kids Relief with NDC 71971-9121 is a a human over the counter drug product labeled by Homeolab International (canada) Inc. The generic name of Kids Relief is drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, coccus cacti, corallium rubrum, stannum 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.

  • DROSERA ROTUNDIFOLIA FLOWERING TOP 1 [hp_C]/100mL
  • ARNICA MONTANA 3 [hp_C]/100mL
  • BRYONIA ALBA WHOLE 3 [hp_C]/100mL
  • IPECAC 3 [hp_C]/100mL
  • CETRARIA ISLANDICA SUBSP. ISLANDICA 1 [hp_C]/100mL
  • COCHINEAL 3 [hp_C]/100mL
  • CORALLIUM RUBRUM WHOLE 3 [hp_C]/100mL
  • TIN 3 [hp_C]/100mL

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)
  • CARAMEL (UNII: T9D99G2B1R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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.
  • 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: 03-03-2018 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 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:Drosera 1CArnica Montana 3CBryonia 3CIpecacuanha 3CCetraria islandica 1CCoccus cacti 3CCorallium rubrum 3CStannum metallicum 3C

Otc - Purpose

PurposeDrosera 1C............................dry coughArnica Montana 3C..................aches and pains, chest congestionBryonia 3C.............................painful coughIpecacuanha 3C......................night coughCetraria islandica 1C...............cough with expectorationCoccus cacti 3C......................cough with expectorationCorallium rubrum 3C...............painful coughStannum metallicum 3C...........coughs, chills and lessens mucusThe letters "HPUS" indicate that the components in this product are officiallymonographed in the Homeopathic Pharmacopoeia of the United States.

Indications & Usage

Uses  This homeopathic medicine is made from acombination of ingredients traditionally used to helprelieve symptoms associated with cough and cold*:•dry cough •cough with expectoration•chest congestion  •fever  •aches and pains

Warnings

WarningsStop use and ask a doctor if •pain or cough gets worse or lastsmore than 5 days ( children) or 7 days (adults)  •fever gets worseor lasts more than 3 days •redness or swelling is present  •newsymptoms occur  •cough comes back or occurs with rash orheadache that lasts. These could be signs of a serious condition.

Dosage & Administration

Directions  •Children under 6 months of age: Consult a licensed healthcare practitioner before using this product•Children 6 months to 2 years old: 2.5ml or 1/2 teaspoonevery 6 hours or 4 times a day  •Children 2 to 12 yearsold: 5ml or 1 teaspoon, every 6 hours or 4 times a day.

Storage And Handling

Other information  •Store at room temperature.•Do not use if seal is broken or missing.

Inactive Ingredient

Inactive ingredients  Purified water, sorbitol,caramel, sodium benzoate, potassium sorbate, citric acid

* Please review the disclaimer below.