Document 58201

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6,37,25 B1
US Pa 6,955,821 B2
d ADAM' 041207
I ~~~!u~ORY 10010014
e 2007, Distibuted by
Adams Respiraory Therapeutcs, Fort Wort. ix 76155
,,
NF; FO&C biue #1 aluminum lake: hypromellose,
USP; magnesium stearate, NF; microcrystallne
ceilulose, NF; sodium starch glycolate, NF
Inactive ingredients carbomer 934P,
. tamper evident do not use if cartn is open
or if seal on bottle printed -SEALED for YOUR
PROTECTION' is broken or missing
. store between 2û-2S"C (68-77"F)
Other information
1 tablet every 12 hours. 00 not exceed,
2 tablets in 24 hours,
. children under 12 years of age: do not use
. adulfs and children 12 years of age and over:
regard for the timing of meals
. do not cruh, chew, or break tablet
. take with a full glass of water
. this product can be administered without
Directions
Drug Facts (continued)
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Title for continued panel:
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00 NOT VARNISH THIS AREA
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Right justifiep
Drug Facts
Active ingredient
Purpose
(in each extended-release
- bi-Iayer tablet)
Guaifenesin 1200 mg...........,.......Expectorant
. for children under 12 years of age
Uses heips loosen phlegm (mucus) and
thin bronchial secretions to rid the bronchial
passageways of bothersome mucus and make
coughs more productive
Warnings
- Do nol us
Ask a doclor before use II you have
. persistent or chronic cough such as occurs
. cough lasts'
with smoking, ashma, chronic bronchitis, or
emphysema
.. cough accompanied by too much phlegm
I
(mucus)
I
I Stop use and ask a doctor If
be signs of a serious ilness,
more than 7 days, comes back. or occurs with
fever, rash, or persistent headache. These could
If pregnant or breast-feeding, ask a health
professional before use.
~
DATA MATRIX
POSITION
-
Graphic leading
to next panel
Keep out of reach of children, In case of
overdose, get medical help or contact a
Poison Control Center right away.
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I RESPIRATORY 10010015
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Ad Resiratry Therapeutcs, FortWort, TX 76155
'- - - - 0.5 pt. hairline 2.
Inactve ingredients caomer 934P, '
NF; FD&C blue #1 aluminum lake; hypromellose,
USP; magnesium stearate, NF; microcrystallne
cellulose, NF; sodium starch glycolate, NF
. tamper evident: do not use if carn Is open
or if seal on botte printed -SEAD for YOUR
PROTECTION" is broken or missing
_ stre beteen 2D-25"C (68' 77"f)
Other information
_ children under 12 years of age: do not use '
2 tablet in 24 hours, ' ,
_ do not crush, chew, or break tablet
_ tae wit a full glas of water
_ this product can be administered without
regard for the timing of meals
_ adults and children 12 years of age and over:
1 tablet every 12 hours, Do not exceed,
Directions
Drug Facts (continued)
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DD NOT VARNISH THIS AREA
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Right justifiep
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Drug Facts :
Ace ingredient Purpose
Gualenesin 1200 mg..........,......Exectant
(in each extnded-release
- bi-Iayer tablet)
IJs helps loosen phlegm (mucus) and
thn bronchial secre1ons to rid the bronchial
pasgeways of bothersome mucus and make
coughs more productive
Warnings
As a doct before use n you have
- Do no us _ tor children undor 12 years of age
. pesistnt or chronic cough such as ocrs
With smokng, asma, chronic bronchit, or
emphysema
- _ CllJgh accompanied by to much phlegm
: (muCls,
, Sto us and all a docr n _ cough lats"
: more than 7 days, comes back, or ocurs wit
i fe-ior, ras. or persistnt headache, These cold
i be signs of a serious Ilness.
,
i If pregnt or breas-feeing, ask a heal
i profesona before use,
i
I Ke ou of reach of chlfdreiln ca of
i overdoe, get medica help or coct a
/ \ ~ "'''wnes- US Pa 6,3,2 81
J.ADAMS
041207
'- US Pa 6,95,821
82
DATA MATRIX
POSITON
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. children under 12 years of age:do not use
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POSITION
~ DATA MATRIX
left justified
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f-1/2"-' AREA
---- -- - - - - - -- ----1-- ---
(1-866-682-4639)
or call 1-866-MUCINEX
Please visit our Web site:
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Directions
. do not crush, chew, or break tablet
. take with a tull glass of water
- . this product can be administered
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Zapf Dingbats - - - - - - - - -,
NDe 634-23-14
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EXPECTORANT
6,37252 Bl
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Headings:
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w~hou regd for tte timing of meals
. adulls and children 12 years of age
and over. 1 tablet every 12 hours.
Do not exood 2 tablets in 24 hours.
. children under 12 years of age:- do not use
or call1-866-MUCINEX
NO VARNISH
POSITON
~ DATA MATRIX
left justified
with 6.5 pt. leading,
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6 pt. Helvetica
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+-1/2"-+ AREA
---- -- ---- -- -- - --1-- - --
(1-866-682-4639)
Please visit our Web site:
ww.mucinexcom
8 pt. Helvetica Bold
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Directions
. do not crush, chew. or break tablet
. take with a full giass of water
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EXPECTORANT
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55/8"
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EXPECTORANT. NASAL DECONGESTANT
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FD&C yellow #6 aluminum lake; hypromellose, USP;
magnesium stearate, NF; microcrystallne cellulose,
NF; sodium starch glycolate, NF
2.5
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31/2"
Drug Facts
Active ingredients Purpose
115/16"
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MucinE~D
1200 mg guaifenesin and 120 mg pseudoephedrine HO
extended,release bi,layer tablets
EXPECTORANT
NASAL DECONGESTANT
Stop use and ask a doctor if
. you get nervous, dizzy,or sleepless
. symptoms do not get better within 7 days, come
(in each extended-release
back or occur with a fever, rash,orpersistent
bi-Iayer tablet)
headache. These could be signs of
a seriousiIness.
Guaifenesin 1200 mg..........................Expectorant
Pseudoephednne HCI120 mg........Nasal Decongestant If pregnant or breast-feeding, ask a health
professional before use.
Uses
Keep out of reach of children. In case of overdose,
. helps loosen phlegm (mucus) and thin bronchiat
getmedjcal help or contact a Poison Control Center,
secretions to rid the bronchialpassagewaysof
right
bothersome mUcus and make coughs more producüve
. temporarilyrelievesnasal congestiondue to:
Directions
hay fever
. commoncold .
. donot crush,chew, or break tablet
. upperrespiratoryallergjes
. take
with a full glass of water
. temporarilyrestores freer breathingthroughthe nose
. this
productcan be administeredwithoutregard for
. promotes nasaland/orsinus drainage
timingof meals
. temporarilyrelievessinus congestionand pressure
. adults
and children 12 years and older:1 lablet
every 12 hours; not more than 2 tablelsin 24 hours
Warnings
under 12 years of age: do not use
. children
Do notuse if you are nowtaking a prescription
monoamine oxidase inhibitor (MAOI) (certain drugs for Other information
depression,psychiatricor emotionalconditions,or
. tamper evident:do not use if printedseal on blister
Parkinson'sdîseasel,orfor2 weeks after stoppingthe
is broken or missing
MAotdrug. If you dOnot knowif your prescriptiondrug
. store at 20-25"C (68,¡¡"F)
coritainsa MAOl,askadoctor orpharmaclst before
Inactive ingredients carbomer 934P, NF;
taking this product.
,
J, AlAMS 041207
"- - - 0.5 pt. hairline
'/ '- US Pat 6,955,821 82
DATA MATRIX
POSITON
II
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~
-Ask a doctor before use if you have
. heart
disease _ high
bloodpressure
. thyroiddisease . diabetes
. trouble uririatirigdue to ari erilargedprostate gland
. persistent or chroniccough such as occurs with
smoking,aslhma, chronicbronchitis,or emphysema
.. cough accompanied by too much phlegm (mucus)
: When using this product
i . do not use more than directed
Bullets:
5 pt. solid square
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No Varnish Area
3.228"
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(82 mm)
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uelNEXlB D 1200 mg guaifenesinl
20 mg pseudoephedrine Hel
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ist. by: Adams Respiratory Therapeutic
art Worth, TX 76155
IIIIIIIII:~ li:a 1111111/ II
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120 mg pseudoephedrine He
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ist. by: Adams Respiratory Therapeutic
Fort Worth, TX 7615
1I11111"1:~ li:a 111/11111
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aximum Strength "-."
Maximum Strengt
3.228"
(82 mil)
ivUelNEXlBD 1200 mg guaifenesinl ~ I MUelNEXlBD 1200 mg guaifenesin
120
mg pseudoephedrine Hei I 120 mg pseudoephedrine He
~i xtended-release bi-Iayer tablet I extended-release bi-Iayer table
ist. by: Adams Respiratory Therapeutics Dist. by: Adams Respiratory Therapeutic i
art Worth, TX 76155 Fort Worth, TX 7615 i
~11111111!iP':qIi~~111 tl~ .1111111111!iP':qIIIIIII~
aximum Strength ~~_ - .ly Maximum Strengt I
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mg pseudoephedrine Hei 120 mg pseudoephedrine He I
. xtended-release bi-Iayer tablet I extended-release bi-Iayer table 'i
ist. by: Adams Respiratory Therapeutic ist. by: Adams Respiratory Therapeutic
art Worth, TX 76155 i Fort Worth. TX 7615 I
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FILE INFORMATION
Job Description: Max Str Mucinex 0 1200/120mg 6ct Blister Pack
Drawing #: 8253.10
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MucinE~DM
extended,release bi,layer tablets
1200 mg guaifenesin and 60 mg dextromethorphan HBr
EXPECTORANT
COUGH SUPPRESSANT
1 15/16"
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MucinE~DM
extended-release bi-Iayer tablets
1200 mg guaifenesin and 60 mg dextromethorphan HBr
EXPECTORANT. COUGH SUPPRESSANT
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EXPECTORANT
COUGH SUPPRESSANT
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Drug Facts (continuedl
,,
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Stop oso and ask a doctor il
. cough lasts more Ihan 7 days, comes back, or
occurs with fever,rash, or persistent headache.
These could be signs of a serious ilness.
,,
Title for continued panel:
8 pt. Helvetica Bold
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left justified
DO NOT VARNISH THIS AREA
(
PurPose
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Right justifiep
Drug Facts
Active ingredients
(in each extended-release
, THERAeEUTICS' US
¡RESPIRATORY 10010016
e 2007. Distibuted by
Adms Respiratory Therapeutcs, For Wort. TX 76155
osc yellow #10 aluminum lake; hypromellose. USP;
magnesium stearate, NF; microcrystallne celluloe, NF;
sodium slarch glycolate, NF
Inactive ingredients carbomer 934P, NF;
. tamper evident: do not use if cartn is open or if
seal on botte printed 'SEALED for YOUR PROTECn
ls brokenor míssing
. store at 20,25'C (68'¡¡"f)
Other information
away. .
bi-Iayer tablet)
If pregnant or breast-feeding, ask a healtl
professional before use.
Dextmetlorphan HBr 6l mg........ Cogh suppressnt
Keep out 01 reach of chlldren,ln case of overdose,
Guailenesin 1200 mg.......,....................Expectoranl
get medical help or contact a Poison Control Center
right
Uses . helps loosen phlegm (mucus) and thin
bronchial secretionsto rid the bronchial passageways
Directions
of bothersme mucus and make coughs more productive . do not crush. chew, or break lablet
. temporarìJyrelieves:
. take with a full glass of waler
. cough due to minor throat ami bronchia! irritation . tlis product can be administered "itlout regard for
as may occur with the common cold or inhaled
timing of meals
irritants
. aduhs and children 12 years and older:
. the intensity of coughing
1 tablet every 12 hours; no1 more than 2 tablets
. the impulse to cough to help you get to Sleep
in 24 hours
. children under 12 years of age: do not use
Warnings
-Do not use _ for children under 12 years of age
. it you are now taking a prescription monoamine
oxidase inhibitor (MAOn (cerlain drugs for
depression, psychiatricor emotional conditions,
or ParkInson's disease), or for 2 weeks after
stopping the MAOI drug. ff you do not know if your
prescription drug contains a MAOI, ask a doctor
or pharmacist before taking this product.
Ask a docor belore use il you have
..8 persistent or chronic cough such as occurs with
i smoking, asthma, chronic bronchitis, or emphysema
i When using this product ' ,
'~ - - 0.5 pt. hairline
Pat
6,3,2 81
d,!, \)
ADA"'
041207
US Pa 6,955,821
82
DATA MATRIX
POSITION
-
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to next panel
I . do not use more than directed IJ
:. cough accompanied by too much phlegm Imucus)
i I
Bullets:
5 pt. solid square
I
I
I
I
,
Zapf Dingbats
Subheadings: - - - - ~ - 6 pt. Helvetica Bold
Condensed,
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DO NOT VARNISH THIS AREA --
115/16"
.
.iih~ ~1111111'''-l''.~/I.Li.
MucinE~DM
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1100 mg guaifenesin and 60 mg dextromethorphan HBr
EXPECTORANT
COUGH SUPPRESSANT
115/16"
MucinE~DM
extended-release bi-Iayer tablets
1200 mg guaifenesin and 60 mg dextromethorphan HBr
EXPECTORANT' COUGH SUPPRESSANT
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Stop use and ask a doctor If
. cough lasls more than 7 days, comes back, or
occurs with fever, rash.or persistent headache.
These could be signs of aserious lloess.
Drug Facts (continued)' ,
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Title for continued panel:
8 pt. Helvetica Bold
Condensed Oblique,
left justified
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Drug Facts
Active ingredients
Directions
away. .
" pregnant or breast-feeding, ask a health
professional before use.
Keep out of reach of children. In case of overdose,
get medical help or contact a Poison Control Center
right
adonotcrush,chew,orbreaktablet
Other information .. "
. taKe with a full glass of water
. this product can be administered without regard for
timing of meals
. adults and children 12 years and older:
1 tabiet evry 12 hours; not more than 2 tablets
in 24 hours
. children under 12 years of age: do not use
Inactive ingredients carbomer 934P, Nf;
. tamper evident do not use jf carton is open or if
seal on batte printed "SEAED lorYOUR PROTECTON
¡sbraken or missing
. store at 20,25°C (5S'77°f)
D&C yellow #10 aluminum lake; hYPlOmellose, USP;
magnesium stearale, Nf; microcrystaline cellulase. Nf;
sodium starch glycolate. Nf
10010017
(Ç 2007. Distibuted by
Adams Respiratory Therapeutics, fort Wort, TX 76155
, TH'W'UT'C'"
I RESPIRATORY
US
'~ - - 0.5 pt. hairline
PaL6,3,22 81
J,!, AD',"
041207
\'? USPaL6,95,82182
DATA MATRIX
POSITION
-
Graphic leading
to next panel
I . do not use mare than directed ~
i Whn using this product ' ,
: . cough accompanied by too much phlegm Imucus;
i ,
Ask a doctor before use n you bave
..a persistent or chronic cough such as occurs with
i smoking, asthma, chronic bronchitis, or emphysema
-Do not use . for children under 12 years of age
. jf you are now taking a prescription monoamine
oxidase inhibitor IMAOQ lcertain drugs lor
depression, psychiatric or emotional conditions,
or Parkinson's disease). or for 2 weeks after
stopping the MAOI drug. ~ you do not know if your
prescriplion drug contains a MAOI. asK a doctor
or pharmacist before taKingthis product.
Warnings
Uses . helps loosen phlegm (mucus) and thin
bronchial secretions to rid the bronclial passageways
of bothersomemucus and make coughsmore productive
. temporarilyrelieves:
. cough due to minor throat and bronchial irritation
as may occur with the cornman cold or inhaled
irritants
. the intensity of coughing
. the impulse to cough to help you get to sleep
Oextomethorphan HBr 50 mg....,....COugh suppresst
Guailenes 1200 mg................;............,Expectorant
1
lin each extended-release
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MucinE~DM
1100 mg guaifenesin and 60 mg dextomethorphan HBr
extended'release bi'layer tablets
EXPECTORANT
COUGH SUPPRESSANT
i
Bullets:
5 pt. solid square
I
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,
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Zapf Dingbats
Subheadings: - - - - - - ~
6 pt. Helvetica Bold
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.
Condensed,
DO NOT VARNISH THIS AREA --
1 15/16"
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.
Headings:
8 pt. Helvetica Bold
Condensed Oblique,
left justified
or call 1-866-MUCINEX
Please visit our Web site:
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,
1
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Directions
without regard for timing of meals
. adutts and children 12 years and
older. 1 tablet every 12 hours;
not more than 2 tablets in 24 hours
. children under 12 years of age:do not use
6,37,2281
NO VARNISH
f-1/2"-' AREA
- -~- - - - - - - - -Body text:
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POSITON
~ DATA MATRIX
-_ - _- _- _- _- _ - _ - _ - _ - _ - _- _- _- _ - _ - _ - _1- _ - _ - _ - _-_
(1-866-682-4639)
. do not crush, chew, or break tablet
. take with a full glass of water
- . this product can be administered
Bullets:
5 pt. solid square
Zapf Dingbats - - - - - - - - -,
NDC 6324-072-14
ir i i l-"l Ii ¡III i i '--: ~ iL '- 1(- i ¡ /11
MucinE~DM
1200 mg guaifenesin and 60 mg dextromethorphan HBr
extended-release bi-Iayer tablets
EXPECTORANT
COUGH SUPPRESSA
Pat
e 2007. Distibuted by Adms Respiratory Therapeutcs, Fort Wort,TX 76155 10040028
.J ~:ltvTlC'- US PaL. 6,95,8 041007
82
J RESPIRATORY US
55/8"
.
.
.
Headings:
Please visit our Web site:
ww.mucinex.com
NO VARNISH
f-1/2"-- AREA
T - - - 2.5 pt. box barline
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with 6.5 pt. leading,
POSITON
. DATA MATRIX
- _ - _ - _- _ - _ - _- _ - _ - _ - _ - _ - _ -_- _ -_ - _ -_1- _ -_ - _ -_ -_
(1-866-682-4639)
or call1-866-MUCINEX
8 pt. Helvetica Bold
Condensed Oblique,
left justified
,
,
,
I
,
Directions
. do not crush, chew, or break tablet
older: 1 tablet every 12 hou,s;
not more than 2 tablets in 24 hours
. children under 12 years of age:do not use
. adults and children 12 years and
without regard for timing of meals
. take wit a full glass of water
- . this product can be administered
Bullets:
5 pt. solid square
Zapf Dingbats - - - - - - - - -,
NDG 63824-072-28
. ií f') l I fll'l, í .. -; .¡ ¿ =- iI- í ; 1"1
MucinE~DM
1200 mg guaifenesin and 60 mg dextromethorphan HBr
extended-release bi-Iayer tablets
EXPECTORANT
COUGH SUPPRESSANT
. THERAPWTlCS- us Pat 6,95,821 82
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\) 041007
J' ÎtEšrlRATORY USPat6,37,25281
e 2007. Distrbutd by Adams Respiratory Therapeutcs, Fort Wort,TX 76155 10040029
55/8"
.