Label: DR. RECKEWEG R49 RHINOPULSAN COMBINATION PRODUCT- arsenicum album 12x, calcarea carbonica 30x, kali bichromicum 12x, mercurius solubilis 30x, mercurius sulphuratus ruber 12x, pulsatilla 12x, sepia 12x, sulphur 30x liquid

  • 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 April 5, 2013

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  • ACTIVE INGREDIENT

    Active ingredients:

    Arsenicum album 12X, Calcarea carbonica 30X, Kali bichromicum 12X, Mercurius solubilis 30X, Mercurius sulphuratus ruber 12X, Pulsatilla 12X, Sepia 12X, Sulphur 30X, 1 g each in 10 g. 

  • PURPOSE


    Purpose

    Relieves symptoms associated with sinusitis


  • INDICATIONS & USAGE


    Uses
    For the temporary relief of minor symptoms associated with sinusitis such as:


    • Sinus headache
    • Nasal congestion
    • Sinus pressure and pain
    • Runny nose
    • Sneezing

  • WARNINGS

    Warnings 

    Ask a doctor before use

    • in children younger than 12 years.

    When using this product

    • in rare cases, hypersalivation may occur after use, in which case the use of the product should be discontinued
    • in very rare cases, skin reactions may occur after use, in which case the product should be discontinued.

    Stop use and ask a doctor if

    • cold persists for more than 7 days
    • fever persists for more than 3 days
    • symptoms worsen or if new symptoms occur.

    If pregnant or breastfeeding, ask a health care professional before use.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children ≥ 12 years 5-10 drops 1-3 times daily, acute cases 4-6 times daily in a little water or undiluted or as recommended.

    Not recommended for children under 12 years of age except under the advice of a health care professional. 

  • OTHER SAFETY INFORMATION

    Other information
    Tamper resistant: do not use if safety ring at base of cap is broken.

    Retain outer carton for full product instructions.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Ethanol, purified water.

  • QUESTIONS


    Questions?

    Call 1-800-361-7872 or email questions@reckeweg.co
  • PRINCIPAL DISPLAY PANEL

    image of carton labelNDC# 53346-1349-5

    Dr. Reckeweg R49 Rhinopulsan

    Homeopathic preparation for the temporary relief of minor symptoms associated with sinusitis such as:

    • Sinus headache
    • Nasal congestion
    • Sinus pressure and pain
    • Runny nose
    • Sneezing

    Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany

    1.68 fl oz
    (50 ml)

  • INGREDIENTS AND APPEARANCE
    DR. RECKEWEG R49 RHINOPULSAN  COMBINATION PRODUCT
    arsenicum album 12x, calcarea carbonica 30x, kali bichromicum 12x, mercurius solubilis 30x, mercurius sulphuratus ruber 12x, pulsatilla 12x, sepia 12x, sulphur 30x liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53346-1349
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 50 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]  in 50 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE12 [hp_X]  in 50 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2, MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIUS SOLUBILIS30 [hp_X]  in 50 mL
    MERCURIC SULFIDE (UNII: ZI0T668SF1) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC SULFIDE12 [hp_X]  in 50 mL
    PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI) PULSATILLA PRATENSIS12 [hp_X]  in 50 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 50 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53346-1349-550 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/1986
    Labeler - PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO (318602612)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO318602612manufacture(53346-1349)
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