TRAMAPAP - tramadol hydrochloride, acetaminophen 
Living Well Pharmacy, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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


Acetaminophen.Granular.USP.label

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

Tramadol 15 GM

  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.

Directions

tramapapuse
TRAMAPAP 
tramadol hydrochloride, acetaminophen kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64038-059
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64038-059-031 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 15 g
Part 21 BOTTLE 75 g
Part 1 of 2
TRAMADOL HCL 
tramadol hydrochloride powder
Product Information
Item Code (Source)NDC:64038-738
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tramadol Hydrochloride (UNII: 9N7R477WCK) (Tramadol - UNII:39J1LGJ30J) Tramadol Hydrochloride1 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64038-738-1515 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/2010
Part 2 of 2
ACETAMINOPHEN CRYSTAL 
acetaminophen powder
Product Information
Item Code (Source)NDC:64038-135
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen1 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64038-135-7575 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/2010
Labeler - Living Well Pharmacy, Inc. (070488957)
Registrant - Living Well Pharmacy, Inc. (070488957)
Establishment
NameAddressID/FEIBusiness Operations
Living Well Pharmacy, Inc.070488957api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Letco830193582api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Spectrum Laboratory Products, Inc.075295246api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Medisca627218576api manufacture

Revised: 5/2010
Document Id: 67469a82-09e3-4671-9776-f72ee54004bf
Set id: e142844d-a0f3-4b33-a3ca-795456bafa1a
Version: 3
Effective Time: 20100525
 
Living Well Pharmacy, Inc.