Sitivig (Page 4 of 4)

How to apply Sitavig

Step 1: Before you apply SITAVIG, find the area on your upper gum, just above either the left or the right incisor. The incisor tooth is the tooth just to the right or left of your two front teeth (See Figure A). This is where you should apply SITAVIG.

Figure A

Fig A


Step 2:

Peel back the cover of the blister pack. Take 1 SITAVIG out of the blister pack. When removed from the blister pack, SITAVIG must be used right away. SITAVIG is round on one side and flat on the other side (See Figure B).

Figure B

Fig B


Step 3: Place the flat side of SITAVIG on your dry fingertip. Apply the round side of SITAVIG to your upper gum (See Figure C). The flat side will be facing the inside of your lip.


Figure C

Fig C

Step 4: Hold SITAVIG in place by applying a slight pressure with your finger on the outside of your upper lip, over the area where SITAVIG is placed, for 30 seconds. This will help SITAVIG stick to your gum (See Figure D).


Figure D

Fig D


Step 5: Leave the SITAVIG tablet in place until it dissolves.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured By:
Farméa
10 rue Bouché Thomas
ZAC d’orgemont
49 000 Angers — France

Distributed By:

Innocutis Holdings LLC

Charleston SC 29401

1-800-449-4468

www.innocutis.com

www.sitavig.com


U.S. Pat. No.: 8,592,434 and
additional patents pending.
©2013 Innocutis Holdings, LLCIssued: April/2013

Label

Label
(click image for full-size original)

SITIVIG acyclovir tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68712-049
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 50 mg in 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
POVIDONE
WATER
HYPROMELLOSE 2208 (15000 MPA.S)
MAGNESIUM STEARATE
COLLOIDAL SILICON DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code AL21
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68712-049-02 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68712-049-01)
1 NDC:68712-049-01 50 mg in 1 BLISTER PACK This package is contained within the CARTON (68712-049-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203791 03/20/2014
Labeler — Innocutis Holdings, LLC (071501252)
Registrant — Innocutis Holdings, LLC (071501252)
Establishment
Name Address ID/FEI Operations
Farmea 286080408 manufacture (68712-049), analysis (68712-049), label (68712-049), pack (68712-049)

Revised: 03/2014 Innocutis Holdings, LLC

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