TRAMAPAP- tramadol hydrochloride, acetaminophen kit

Tramapap by

Drug Labeling and Warnings

Tramapap by is a Prescription medication manufactured, distributed, or labeled by Living Well Pharmacy, Inc., Letco, Spectrum Laboratory Products, Inc., Medisca. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

DESCRIPTION

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.

INDICATIONS & USAGE

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

DRUG & OR LABORATORY TEST INTERACTIONS

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

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

WARNINGS AND PRECAUTIONS

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.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRAMAPAP 
tramadol hydrochloride, acetaminophen kit

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64038-059-03	1 in 1 KIT

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
Item Code (Source)	NDC: 64038-738
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Tramadol Hydrochloride (UNII: 9N7R477WCK) (Tramadol - UNII:39J1LGJ30J)	Tramadol Hydrochloride	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64038-738-15	15 g in 1 BOTTLE

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
Item Code (Source)	NDC: 64038-135
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64038-135-75	75 g in 1 BOTTLE

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	Business Operations
Living Well Pharmacy, Inc.		070488957	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Letco		830193582	api manufacture

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

Establishment
Name	Address	ID/FEI	Business Operations
Medisca		627218576	api manufacture