RANITIDINE HYDROCHLORIDE ORAL SUSPENSION KIT- ranitidine hydrochloride kit
Ranitidine Hydrochloride Oral Suspension Kit by
Drug Labeling and Warnings
Ranitidine Hydrochloride Oral Suspension Kit by is a Prescription medication manufactured, distributed, or labeled by California Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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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
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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
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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
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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
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INGREDIENTS AND APPEARANCE
RANITIDINE HYDROCHLORIDE ORAL SUSPENSION KIT
ranitidine hydrochloride kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70332-109 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70332-109-01 1 in 1 KIT 01/02/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 6.4 g Part 2 1 BOTTLE 250 mL Part 1 of 2 RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride powder, for suspensionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 6.4 g in 6.4 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 6.4 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2016 Part 2 of 2 ORAL VEHICLE
oral vehicle suspensionProduct Information Route of Administration ORAL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor PINEAPPLE (PINEAPPLE;ORANGE) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 250 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/02/2017 Labeler - California Pharmaceuticals, LLC (021420944) Registrant - California Pharmaceuticals, LLC (021420944) Establishment Name Address ID/FEI Business Operations California Pharmaceuticals, LLC 021420944 repack(70332-109) , manufacture(70332-109)
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