Sinecch
FDA Label NDC 63545-142

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hahnemann Laboratories, Inc. Dba Alpine Pharmaceuticals for the product Sinecch (NDC 63545-142). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, uses, warnings, drug interactions, storage, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Active Ingredients: SinEcch 01 500mg Arnica Montana 1M, SinEcch 02 500mg Arnica Montana 12C

Purpose

surgical recovery regimen

Reduces Pain, Bruising, and Swelling after Surgery or Major Trauma.

Keep Out Of Reach Of Children

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

Uses

Surgery or Major Trauma

Warnings

Warnings: If you are pregnant or nursing, consult your physician before taking SinEcch. For multiple procedures during a 4 week interval, take only 1 SinEcch regimen with the final procedure.

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

Drug Interactions

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 6. Swallow the capsule with water, or twist open the capsule and pour contents into your mouth. Let the small pellets dissolve.

SinEcch                                        SURGERY                                            MAJOR TRAUMA

Directions for Using the                         Facial Surgery, Liposuction,          Major injuries from Accidents,

Capsule Labeled:                            Body Contouring, or                         Falls, Sports Injuries, or when

                                                                     General Surgery                                Starting after Surgery

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PRE-OP (SinEcch 01                            1-24 hours                                            As soon as possible after

Orange/Peach Color                              before surgery                                    the surgery or trauma

___________________________________________________________________________________

POST-OP (SinEcch 01)                      1-6 hours                                             4 hours after the

Orange/Peach Color                             after surgery                                       first dose

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BEDTIME (SinEcch 01)                      Bedtime on the day of                    Bedtime the same day as

Orange/Peach Color                             surgery (Day 1)                         the above doses (Day 1)

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DAYS 2, 3, AND 4                             1 capsule every morning                    1 capsule every morning

(SinEcch 02)                                        1 capsule every afternoon                 1 capsule every afternoon

Peach/Peach Color                          1 capsule every evening                     1 capsule every evening

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Inactive Ingredients

Inactive Ingredients : Sucrose 400mg, Lactose 100 mg, Capsules contain Hypromellose, Red Iron Oxide, Titanium Dioxide

Package Label

SinEcch tm  Homeopathic Arnica Montanan

surgical recovery regimen   Professional Strength

Clinically Proven to Reduce Bruising and Swelling after Surgery

ALL NATURAL    12 capsules  THIS PRODUCT IS SAFETY SEALED. THE BOX IS SEALED AND THE CAPSULES ARE INDIVIDUALLY BLISTER SEALED. DO NOT USE IF SEALS ARE BROKEN.

Printed with soy based inks.

Developed and distributed by Alpine Pharmaceuticals, San Rafael, CA 94901 a wholly owned subsidiary of Hahnemann Laboratories, Inc. All rights reserved. Made in the USA

Questions or comments call 888.SINECCH (888-746-3224)  email: [email protected] or visit online at www.alpinepharma.com

A Product of Alpine Pharmaceuticals    The Arnica Experts! tm


Sinecch 1 Label (Hanmemann Sinecch Front)

Sinecch 1 Label (Hanmemann Sinecch Front)

Sinecch 2 Label (Hanmemann Sinecch Back)

Sinecch 2 Label (Hanmemann Sinecch Back)

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