Label: RANITIDINE HYDROCHLORIDE ORAL SUSPENSION KIT- ranitidine hydrochloride kit

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated January 5, 2018

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  • Instructions for Preparation Page 1 Page 2

    NDC 70332-109-01

    For Prescription Compunding Only

    Rx only

    Ranitidine Hydrochloride Oral Suspension

    Ranitidine hydrochloride 25.0mg/mL [equivalent to 22.4 mg/mL rantidine]

    Pineapple/Orange oral suspension - kit

    Ranitidine Hydrochloride Oral Suspension kits provide a convenient approach to rapidly prepare prescription medications, as all components are pre-measured. This kit is manufactured according to US FDA current Good Manufacturing Practice (cGMP).

    Description:

    This kit contains active and inactive materials to prepare 250mL of a ranitidine hydochloride Pineapple/Orange oral suspension containing 25.0 mg/mL ranitidine Hydrochloride [equivalent to 22.4 mg/mL ranitidine]. This kit may only be used for prescriptioncompounding by an appropriate licensed medical professional, in response to a physician's prescription, to create a medication tailored to the specialized needs of an individual patient.

    Contents:

    - 6.4 ranitidine hydrochloride USP [equivalent to 5.7 g ranitidine]

    - 250mL Pineapple/Orange oral suspension vehicle (purified water, glycerin, xylitol, monoammoniumium glycyrrhizinate, pineapple flavor,

    orange flavor, potassium sorbate, xanthan gum, sodium benzoate, citric acid, sodium

    citrate)

    - Press-in bottle adaptor

    - Oral dispenser

    - Instructions

    Pharmacist Instructions for Preparation

    1 Remove and Inspect the Contents of the Kit

    Ensure that the safety seals are present and intact on the ranitidine hydrochloride and pineapple/orange oral suspension vehicle bottles. If the seals are not intact, do not use the kit.

    2 Prepare for Compounding

    Wear gloves and eye protection during combining operations. Remove the seal from the Pineapple/Orange oral suspension bottle. Break the perforated seal and remove the cap from the ranitidine hydrochloride bottle.

    3 Transfer Ranitidine Hydrochloride to the Pineapple/Orange Suspension Bottle

    Uncap the Pineapple/Orange suspension bottle. Pour a small amount of Pineapple/Orange suspension liquid (approximately one-third to one-half the volume of the ranitidine hydrochloride bottle) into the ranitidine hydrochloride bottle. Cap the ranitidine hydrochloride bottle and shake well several times to dissolve the ranitidine hydrochloride powder. Empty the contents into the Pineapple/Orange suspension bottle. Cap and mix the suspension bottle. Repeat this step a minimum of 3 times. Visually ensure that all of the renitidine hydrochloride has been dissolved and transferred to the suspension bottle.

    4 Completing the Compounding Process

    Insert the press-in bottle adaptor into the Pineapple/Orange suspension bottle that now contains the renitidine hydrochloride. Recap the Pineapple/Orange suspension bottle. Mix well by inverting repestedly several times. Visually ensure that all contents are dissolved.

    5 Re-label the Resulting Final Suspension

    Label the resulting final suspension as required for prescription products. Ensure that the original Pineapple/Orange oral suspension vehicle label is removed or obscured, since the original label is no longer accurate once the resulting final suspension is completed. The contents of the bottle need to be shaken well before taken as directed by the medical professional.

    Store the unused kit at room temperature of 15-30°C (59-86°F). once prepared, store the mixed suspension between 2-8°C (36-46°F). The resulting final suspension is stable for up to eight weeks, based upon real-time and accelerated stability studies.

    An oral dispenser is provided in the kit and may be used to facilitate delivery of the suspension.

    U.S. Patents Pending

    Repackaged and Distributed by:

    California Pharmaceuticals LLC

    768 Calle Plano

    Camrillo, CA 93012

    California

    PHARMACEUTICALS LLC

    CS43-A1 rev 3

    Ranitidine Hydrochloride Insert 1

    Ranitidine Hydrochloride Insert 2

  • Ranitidine Hydrochloride Product Label

    Do not use if safety seal is broken

    Ranitidine Hydrochloride

    1, 1-Ethenediamine, N-[2-[[[5-[(dimethylamino)methyl]-2furanyl]-methyl]thio]ehtyl]-N-methyl-2-nitro, monohydrochloride

    CAS # 66357-59-3

    Net contents: 6.4 g

    Repackaged by:

    California Pharmaceuticals, LLC

    Camarillo, CA 93012

    California

    PHARMACEUTICALS

    CS130-A1 rev 1

    Ranitidine Hydrochloride Label

  • Oral Suspension Label

    Do not use if safety seal is broken

    Pineapple/Orange Oral Suspension Vehicle

    Sugar, dye, and paraben free

    Ingredients: purified water, glycerin, xylitol, monoammoniumium glycyrrhizinate, pineapple flavor, orange flavor, potassium sorbate, xanthan gum, sodium benzoate, citric acid, sodium citrate

    Net contents: 250 mL (8.4 fl oz)

    Manufactured for:

    California Pharmaceuticals LLC

    Camarillo, Ca 3012

    California

    PHARMACEUTICALS LLC

    CS36-A-1 rev 2

    Oral Suspension Vehicle Label

  • Ranitidine Hydrochloride Oral Suspension Pineapple/Orange Oral Suspension Kit Label

    NDC 70332-109-01

    Rx only

    Ranitidine Hydrochloride Oral Suspension and Pineapple/Orange Oral Suspension Kit

    (ranitidine hydrochloride 25.0 mg/mL [equivalent to 22.4 mg/mL rantidine],

    in a Pineapple/Orange oral suspension kit) Histamine-2 blocker

    Description:

    This kit contains active and inactive materials to prepare 250mL of a ranitidine hydochloride Pineapple/Orange oral suspension containing 25.0 mg/mL ranitidine hydrochloride [equivalent to 22.4 mg/mL ranitidine]. This kit may only be used for prescriptioncompounding by an appropriate licensed medical professional, in response to a physician's prescription, to create a medication tailored to the specialized needs of an individual patient.

    Active Ingredients:

    - 6.4 ranitidine hydrochloride USP [equivalent to 5.7 g ranitidine]

    Inactive Ingredients:

    - 250mL Pineapple/Orange oral suspension vehicle (purified water, glycerin, xylitol, monoammoniumium glycyrrhizinate, pineapple flavor,

    orange flavor, potassium sorbate, xanthan gum, sodium benzoate, citric acid, sodium

    citrate)

    - Press-in bottle adaptor

    - Oral dispenser

    - Instructions

    U. S. Patents Pending

    Do not use if safety seal is broken

    Store kit at room temperature,

    15-30°C (59-86°F).

    California

    PHARMACEUTICALS LLC



    Repackaged and Distributed by:

    California Pharmaceuticals, LLC

    768 Calle Plano

    Camarillo, Ca 93012

    CS129-A1 rev 2

    Ranitidine Hydrochloride Principle Display

  • INGREDIENTS AND APPEARANCE
    RANITIDINE HYDROCHLORIDE ORAL SUSPENSION KIT 
    ranitidine hydrochloride kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70332-109
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70332-109-011 in 1 KIT01/02/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 6.4 g
    Part 21 BOTTLE 250 mL
    Part 1 of 2
    RANITIDINE HYDROCHLORIDE 
    ranitidine hydrochloride powder, for suspension
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE6.4 g  in 6.4 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    16.4 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2016
    Part 2 of 2
    ORAL VEHICLE 
    oral vehicle suspension
    Product Information
    Route of AdministrationORAL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPINEAPPLE (PINEAPPLE;ORANGE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/02/2017
    Labeler - California Pharmaceuticals, LLC (021420944)
    Registrant - California Pharmaceuticals, LLC (021420944)
    Establishment
    NameAddressID/FEIBusiness Operations
    California Pharmaceuticals, LLC021420944repack(70332-109) , manufacture(70332-109)