NDC 63545-516 Sinecchi

Arnica Montana

NDC Product Code 63545-516

NDC CODE: 63545-516

Proprietary Name: Sinecchi 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: Arnica Montana 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.

Product Characteristics

Color(s):
ORANGE (C48331 - ORANGE/PEACH)
Shape: CAPSULE (C48336)
Size(s):
18 MM
Imprint(s):
SINECCH01
Score: 1

NDC Code Structure

  • 63545 - Hahnemann Laboratories Inc. Dba Alpine Pharmaceuticals

NDC 63545-516-01

Package Description: 4 CAPSULE in 1 BLISTER PACK

NDC Product Information

Sinecchi with NDC 63545-516 is a a human over the counter drug product labeled by Hahnemann Laboratories Inc. Dba Alpine Pharmaceuticals. The generic name of Sinecchi is arnica montana. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Hahnemann Laboratories Inc. Dba Alpine Pharmaceuticals

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

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.

Sinecchi 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.

  • ARNICA MONTANA 1 [hp_M]/1

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.

  • SUCROSE (UNII: C151H8M554)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Hahnemann Laboratories Inc. Dba Alpine Pharmaceuticals
Labeler Code: 63545
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: 02-21-2020 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.

Sinecchi Product Label Images

Sinecchi 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

Medicinal Ingredients:


SinEcch 01 500mg Arnica Montana (Whole plant) 1M, SinEcch 02 500mg Arnica Montana (Whole plant) 12C

Purpose

Homeopathic Remedy

Keep Out Of Reach Of Children

Keep this and all medication out of the reach of children.

Uses

Uses: Homeopathic Remedy

Warnings

Warnings: Consult a health care practitioner before use if you are pregnant or breastfeeding. Consult a health care practitioner if symptoms persist or worsen.


Do not drink or eat anything for 15 minutes before and after taking SinEcch.

Drug Interactions

Do not take together with Talwin tm or Talwin NX tm

Storage

Storage: Store at room temperature.

Directions

Directions: For adults and children over 12 years. Take one capsule every six hours starting as soon as possible after procedure. Swallow the capsules with water or twist open the capsule and pour contents into your mouth. Let the small pellets dissolve.

Inactive Ingredients

Non-medicinal Ingredients:Sucrose/lactose. Capsules contain Hypromellose, Iron Oxide (Fe203), Titanium Dioxide

Package Label

SINECCHi TMRecommended by Health Care PractitionersHomeopathic Arnica montanaSINECCHi TMHomeopathic RemedyHigh Potency Homeopathic Arnica montana


ALL NATURAL4 capsulesDIN-HM80027840Lot# SIQU11 Use before May 2016Developed by Alpine Pharmaceuticals, San Rafael, CA 94901 a wholly owned subsidiary of Hahnemann Laboratories, Inc. All rights reserved. Made in  USA


NDC63545-516-01Questions or Comments: Call 011-415-6978 or visit online at www.alponepharm.com   Imported by: Eastern Canada: SCM Products Inc. 1-888-710-4697   Western Canada: Miza Alladina Medical Ltd. 1-888-429-4499This product is safety sealed. The box is sealed and the capsules are individually blister sealed. Do not use if seals or blisters are broken. Do not use together with Talwin TM, or Talwin NX TM.

* Please review the disclaimer below.