FDA Label for Ranitidine Hydrochloride Oral Suspension Kit

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 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

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

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