NDC 59262-265 Kids Cough And Cold Relief Plus Echinacea, Nighttime

Atropa Belladonna, Matricaria Recutita, Copper, Drosera Rotundifolia Flowering Top, Echinacea Pallida, Ferrosoferric Phosphate, Polygala Senega Root And Zinc

NDC Product Code 59262-265

NDC 59262-265-25

Package Description: 1 BOTTLE in 1 BOX > 118 mL in 1 BOTTLE

NDC Product Information

Kids Cough And Cold Relief Plus Echinacea, Nighttime with NDC 59262-265 is a a human over the counter drug product labeled by Similasan Corporation. The generic name of Kids Cough And Cold Relief Plus Echinacea, Nighttime is atropa belladonna, matricaria recutita, copper, drosera rotundifolia flowering top, echinacea pallida, ferrosoferric phosphate, polygala senega root and zinc. The product's dosage form is syrup and is administered via oral form.

Labeler Name: Similasan Corporation

Dosage Form: Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.

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 Cough And Cold Relief Plus Echinacea, Nighttime 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.

  • ATROPA BELLADONNA 6 [hp_X]/mL
  • MATRICARIA RECUTITA 8 [hp_X]/mL
  • COPPER 12 [hp_X]/mL
  • DROSERA ROTUNDIFOLIA FLOWERING TOP 4 [hp_X]/mL
  • ECHINACEA PALLIDA 6 [hp_X]/mL
  • FERROSOFERRIC PHOSPHATE 12 [hp_X]/mL
  • POLYGALA SENEGA ROOT 6 [hp_X]/mL
  • ZINC 12 [hp_X]/mL

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

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: Similasan Corporation
Labeler Code: 59262
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: 02-01-2016 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: 12-31-2021 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 Cough And Cold Relief Plus Echinacea, Nighttime Product Label Images

Kids Cough And Cold Relief Plus Echinacea, Nighttime 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

Active Ingredient

Belladonna* 6X

Chamomilla (chamomile) 8X

Cuprum metallicum (copper) 12X

Drosera (sundew) 4X

Echinacea (pale purple coneflower) 6X

Ferrum phosphoricum (iron phosphate) 12X

Senega officinalis (mountain flax) 6X

Zincum metallicum (zinc) 12X

Purpose

Sore throat, nighttime cough, mucus

Mucus, dry cough, restlessness

Hoarseness, mucus, dry cough

Nighttime spasmodic/hacking/tickling cough

Immune stimulant

Hoarseness, mucus, tickling cough

Nasal congestion, mucus dry/hacking/tickling cough

Roughness/dryness/soreness in throat, tickling cough

Uses:

  • According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: CoughMucus CongestionImmunity Support

Warnings:

  • According to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms).Do not exceed recommended dosage.Not intended for children under 2.A persistent cough may be a sign of a serious condition.Do not use in case of hypersensitivity/allergy to the ingredients

If Pregnant, Trying To Get Pregnant Or Breast Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Stop Use And Ask A Doctor If

Symptoms worsen or persist for more than 72 hours

Directions:

  • For children age 2 and over:AGEDOSEFREQUENCY2-122.5 ml (½ tsp)3 to 6 times daily (every 4 hours)12+5 ml (1 tsp)3 to 6 times daily (every 4 hours)Replace cap tightly after every useOr use as directed by a licensed health care professional.

Other Information:

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

Citric acid, Grape flavor, Purified water, Sorbitol Questions? Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com www.SimilasanUSA.com*containing 0.0000000016% alkaloids calculated as hyoscyamine

* Please review the disclaimer below.