SYMFI (Page 16 of 16)

PRINCIPAL DISPLAY PANEL — 600 mg/300 mg/300 mg

NDC 49502-475-93 Rx only

SYMFI®
(efavirenz, lamivudine,
and tenofovir disoproxil
fumarate) tablets
600 mg/300 mg/300 mg*

Note to pharmacist: Do not cover
ALERT box with pharmacy label.

ALERT: Find out about
medicines that should NOT
be taken with SYMFI®.

30 tablets

*Each film-coated tablet contains:
Efavirenz, USP 600 mg
Lamivudine, USP 300 mg
Tenofovir Disoproxil Fumarate 300 mg
(equivalent to 245 mg of tenofovir
disoproxil)

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication
out of the reach of children.

Store below 30°C (86°F).

Dispense only in original container.
Keep container tightly closed.

Manufactured for:
Mylan Specialty L.P.
Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MP/DRUGS/25/1/2014

MS:MXI:47593:1C:R3

Mylan.com

SYMFI® is a registered
trademark of Mylan Pharmaceuticals Inc.

Symfi Tablets 600 mg/300 mg/300 mg Carton Label
(click image for full-size original)
SYMFI efavirenz, lamivudine and tenofovir disoproxil fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49502-475
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EFAVIRENZ (EFAVIRENZ) EFAVIRENZ 600 mg
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 300 mg
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR ANHYDROUS) TENOFOVIR DISOPROXIL FUMARATE 300 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM CHLORIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule shaped) Size 23mm
Flavor Imprint Code M;152
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49502-475-93 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (49502-475-93)
2 NDC:49502-475-77 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (49502-475-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022142 04/25/2018
Labeler — Mylan Specialty L.P. (194775557)

Revised: 10/2019 Mylan Specialty L.P.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.