NDC 43406-0664 Cough Syrup

Camphor (natural), Arsenic Trioxide, Bryonia Alba Root, Drosera Rotundifolia, Ipecac, Potassium Carbonate, Phosphorus, Anemone Pulsatilla, Spongia Officinalis Skeleton, Roasted, Drimia Maritima Whole

NDC Product Code 43406-0664

NDC 43406-0664-4

Package Description: 120 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Cough Syrup with NDC 43406-0664 is a a human over the counter drug product labeled by Natural Creations, Inc.. The generic name of Cough Syrup is camphor (natural), arsenic trioxide, bryonia alba root, drosera rotundifolia, ipecac, potassium carbonate, phosphorus, anemone pulsatilla, spongia officinalis skeleton, roasted, drimia maritima whole. The product's dosage form is syrup and is administered via oral form.

Labeler Name: Natural Creations, Inc.

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.

Cough Syrup 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.

  • CAMPHOR (NATURAL) 30 [hp_C]/mL
  • ARSENIC TRIOXIDE 30 [hp_C]/mL
  • BRYONIA ALBA ROOT 30 [hp_C]/mL
  • DROSERA ROTUNDIFOLIA 30 [hp_C]/mL
  • IPECAC 30 [hp_C]/mL
  • POTASSIUM CARBONATE 30 [hp_C]/mL
  • PHOSPHORUS 30 [hp_C]/mL
  • ANEMONE PULSATILLA 30 [hp_C]/mL
  • SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_C]/mL
  • DRIMIA MARITIMA WHOLE 30 [hp_C]/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.

  • ACACIA (UNII: 5C5403N26O)
  • ANISE OIL (UNII: 6Y89129C8H)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CHAMOMILE (UNII: FGL3685T2X)
  • ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
  • CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1)
  • ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
  • MULLEIN LEAF (UNII: 9936O846LI)
  • MUSA X PARADISIACA LEAF (UNII: 2UIJ27N6ED)
  • RED CLOVER (UNII: L9153EKV2Y)
  • URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
  • THYME (UNII: CW657OBU4N)
  • HONEY (UNII: Y9H1V576FH)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)

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: Natural Creations, Inc.
Labeler Code: 43406
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: 05-07-2007 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.

Cough Syrup Product Label Images

Cough Syrup 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*): Camphora 3X, 30C, Arsenicum Album 30C, Bryonia Alba 30C, Drosera Rotundifolia 30C, Ipecacuanha 30C, Kali Carbonicum 30C, Phosphorus 30C, Pulsatilla 30C, Spongia Tosta 30C, Squilla Maritima 30C.

Indications & Usage

USES: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**

Otc - Purpose

USES: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**

Dosage & Administration

DIRECTIONS: Adults & children above 4 years: 1 teaspoon (5mL) every 2-3 hours, or as directed by a health care professional. Shake well before use.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF THE REACH OF CHILDREN. In case ov overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Warnings

  • WARNINGS:Consult a physician for use in children under 12 years of age.IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.Do not use if TAMPER EVIDENT seal is broken or missing.

Inactive Ingredient

INACTIVE INGREDIENTS: Acacia Gum, Anise Oil, Citric Acid, Eucalyptus Oil, Glycerin, Herbal Base [Chamomile (flower), Echinacea Angustifolia (Flower), Iceland Moss (Herb), Marshmallow (Root), Mullein (Leaf), Plantain (Leaf), Red Clover (Flower), Stinging Nettle (Leaf), Thyme (Herb)], Honey, Natural Cherry Flavor, Natural Mixed Berry Flavor, Potassium Sorbate, Purified Water.

Otc - Questions

QUESTIONS & COMMENTS?Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

References

*The letters "HPUS" indicate the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.**These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

* Please review the disclaimer below.