Label: SINECCH- arnica montana capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated September 21, 2015

If you are a consumer or patient please visit this version.

  • 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

    ___________________________________________________________________________________

    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

    __________________________________________________________________________________

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

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

    __________________________________________________________________________________

    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

    __________________________________________________________________________________

  • 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: info@alpinepharm.com or visit online at www.alpinepharma.com

    A Product of Alpine Pharmaceuticals    The Arnica Experts! tm


    SinEcch 1 Label

    SinEcch 2 Label

  • INGREDIENTS AND APPEARANCE
    SINECCH 
    arnica montana capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-142
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_M]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (orange/peach) Scoreno score
    ShapeCAPSULE (capsule) Size18mm
    FlavorImprint Code SinEcch01
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-142-0112 in 1 BLISTER PACK; Type 0: Not a Combination Product06/30/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/30/1998
    Labeler - Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals (147098081)
    Registrant - Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals (147098081)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals147098081manufacture(63545-142)