Tramapap

Generic Name: tramadol hydrochloride, acetaminophen

Dosage Form: compounding kit
Tramapap

LWP

381 Van Ness Ave. Suite 1507

Torrance CA, 90501

S/N: LWP304326                              3/29/2010                     LWP,MD

ACETAMINOPHEN GRANULAR, USP #75 GM

BATCH: 03292010Z                                                            HEALTH: 1

MFG: LIVING WELL PHARMACY                                        FIRE: 1

NDC: 64038-0135-75                                                           REACTIVITY: 0

CAS #: 103-90-2

LWP

381 Van Ness Ave. Suite 1507

Torrance CA, 90501

S/N: LWP307039                              4/6/2010                     LWP,MD

TRAMADOL HCL #15GM

BATCH: 04062010Z                                                            HEALTH: 2

MFG: LIVING WELL PHARMACY                                        FIRE: 1

NDC: 64038-0738-15                                                           REACTIVITY: 0

CAS #: 73806-49-2

1. RX Only

For Prescription Compounding Only

Tramapap Kit

Tramadol HCl and Acetaminophen Compound Kit


Description


Each Tramapap Kit is comprised of 15 grams of tramadol hydrochloride powder and  75 grams of acetaminophen powder.


Certificate of Analysis on File


Tramapap Kit also contains 23.25 grams of Lactose Monohydrate (Spray dried) powder and 1.5 grams of

riboflavin USP powder. When compounded, the final product provides a homogeneous product of 300

capsules each capsule containing 50mg of tramadol and 250mg of acetaminophen.

Equipment

Required supplies needed to compound this kit

Equipment

Item	Quantity
Tramadol HCl (Included)	15 grams
Acetaminophen (Included)	75 grams
Lactose Monohydrate Spray Dried Powder ( Included)	23.25 grams
Riboflavin Powder (Included)	1.5 grams
Red/Blue #1 Capsules ( Required Not Included)	300 Capsules

Equipment

Recommended supplies not included in this kit

Equipment

Item	Quantity
16 oz Glass Mortar and Pestle	1 each
300 Capsule Machine Number 2 Notch	1
Scraper ( Recommended Not Included)	1
Tamper (Recommended Not Included)	1
Capsule Locker (Recommended Not Included)	1

Directions

1. Using a 16 oz mortar and pestle triturate powders well to reduce particle size until uniform.

2. Using a 300 capsule machine encapsulate triturate powder mixture into number 1 red/blue capsules

Prior to compounding, store Tramapap Kit at room temperature. Store the final product at room temperature.

Final product for oral use only. Keep out the reach of children. Compounded product, as dispensed,

is stable for at least 180 days or the time remaining on the expiration date of any given ingredient,

which ever is shorter.

Tramapap  tramadol hydrochloride, acetaminophen  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64038-059

Packaging # NDC Package Description Multilevel Packaging 1 64038-059-03 1 KIT In 1 KIT None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE   15 g Part 2 1 BOTTLE   75 g

Part 1 of 2 TRAMADOL HCL  tramadol hydrochloride  powder

Product Information NDC Product Code (Source) 64038-738     Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tramadol Hydrochloride (Tramadol) Tramadol Hydrochloride 1 g  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64038-738-15 15 g In 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/07/2010

Part 2 of 2 ACETAMINOPHEN CRYSTAL  acetaminophen  powder

Product Information NDC Product Code (Source) 64038-135     Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (Acetaminophen) Acetaminophen 1 g  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64038-135-75 75 g In 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/07/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/07/2010

Labeler - Living Well Pharmacy, Inc. (070488957)

Registrant - Living Well Pharmacy, Inc. (070488957)

Establishment
Name	Address	ID/FEI	Operations
Living Well Pharmacy, Inc.		070488957	api manufacture

Establishment
Name	Address	ID/FEI	Operations
Letco		830193582	api manufacture

Establishment
Name	Address	ID/FEI	Operations
Spectrum Laboratory Products, Inc.		075295246	api manufacture

Establishment
Name	Address	ID/FEI	Operations
Medisca		627218576	api manufacture

Revised: 05/2010Living Well Pharmacy, Inc.

More Tramapap resources

• Tramapap Side Effects (in more detail)
• Tramapap Use in Pregnancy & Breastfeeding
• Tramapap Drug Interactions
• Tramapap Support Group
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