FDA Label for Tramapap
View Indications, Usage & Precautions
Tramapap Product Label
The following document was submitted to the FDA by the labeler of this product Living Well Pharmacy, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Package Label.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 #: 103-90-2LWP
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 #: 73806-49-2Description
- 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
| 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
| 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.
* Please review the disclaimer below.
