Tramapap
FDA Label NDC 64038-059

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Living Well Pharmacy, Inc. for the product Tramapap (NDC 64038-059). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, description, indications & usage, drug & or laboratory test interactions, dosage & administration, storage and handling, warnings and precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 #: 103-90-2

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

Description

  • 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.

* Please review the disclaimer below.