Tramapap

Generic Name: tramadol hydrochloride, acetaminophen
Dosage Form: compounding kit

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.

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 LABEL Item Code (Source) NDC:64038-059
Packaging
# Item Code Package Description
1 NDC:64038-059-03 1 KIT (KIT) 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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tramadol Hydrochloride (Tramadol) Tramadol Hydrochloride 1 g  in 1 g
Packaging
# Item Code Package Description
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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 1 g  in 1 g
Packaging
# Item Code Package Description
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 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: 05/2010
 
Living Well Pharmacy, Inc.



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