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From: Mr Alok Tholiya <tholiya@...>
Subject: "do not use" for children under 4 years
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Alok adds:
1.In our country India we dont hear such ethical practice by associations/ =
unions. Rather they are all ( be it taxi or airlines or pharma or tobacco o=
r gutka or=C2=A0any group) cater to only interests of own group.But in USA =
Consumer Healthcare Products Association (CHPA), voluntarily announced labe=
lling warnings read on.......
2. Indian / aharashtra FDA does not have such useful informative site like =
FDA USA which gives latest updates for citizens and consumers.
3. Newspapers r busy covering khans, B's , naked,s, promting ladies bars et=
c. See the contents of daily newspapers.How many=C2=A0 pages are for what p=
urpose.
________________________________
Patients Are Asking
=20
New Labels for Non-prescription Cough and Cold Medications=20=20
Most makers of nonprescription cough and cold medicines are voluntarily cha=
nging the labels on these products to say "do not use" for children under 4=
years of age. New child resistant packaging and measuring devices are also=
being introduced.=20
The changes were recently announced by the Consumer Healthcare Products Ass=
ociation (CHPA), which represents most of these manufacturers. FDA supports=
this action, which reflects a more restrictive use of these drugs in child=
ren.
FDA is working with other public health and scientific organizations to obt=
ain, analyze and make available the most up-to-date information about the e=
ffects of these medicines on children, and FDA will take additional action =
as needed. In the meantime, here are some reminders for parents and caregiv=
ers:
=E2=80=A2 First, understand that these medicines do not cure a cold or coug=
h or shorten its duration. They only treat a child's symptom(s) such as a r=
unny nose, congestion, fever and aches.=20
=E2=80=A2 Do not give children medications labeled only for adults.
=E2=80=A2 Choose OTC cough and cold medicines with child-resistant safety c=
aps, where possible. Be sure to close the cap tightly after use, and store =
the medication out of reach of children.
=E2=80=A2 Check the "Drug Facts" on the label, which tells how much medicin=
e to give and how often to give it. Misusing or using too much of these pro=
ducts can cause serious and even life threatening side effects such as rapi=
d heartbeat, drowsiness, suppression of the respiratory system and seizures=
.=20
=E2=80=A2 Be careful when giving a child more than one medicine. Using two =
medicines with the same or similar active ingredients could give a child to=
o much of that drug.=20
=E2=80=A2 Only use measuring devices that come with the medicine, or those =
specially made for measuring drugs.=20
=E2=80=A2 Finally, if you have questions or are not sure how to use a produ=
ct, check with the doctor or pharmacist.
Additional Information:
FDA MedWatch Safety Alert. Over The Counter Cough and Cold Medications. Oct=
ober 9, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#CoughCold=20
Return to Top Return to FDA Patient Safety News Home=20
________________________________
FDA Patient Safety News is a product of the US Federal Government, and as s=
uch is NOT copyrighted or restricted in any way. We encourage the further u=
se and distribution of the video or text of the program by anyone =E2=80=93=
either in its entirety or as individual stories.
________________________________
FDA Home | Search FDA Site | A-Z Index | Contact FDA | Privacy | Accessibil=
ity
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<html><head><style type=3D"text/css"><!-- DIV {margin:0px;} --></style></he=
ad><body><div style=3D"font-family:Courier New, courier, monaco, monospace,=
sans-serif;font-size:12pt"><DIV></DIV>
<DIV>Alok adds:</DIV>
<DIV> </DIV>
<DIV>1.In our country India we dont hear such ethical practice by associati=
ons/ unions. Rather they are all ( be it taxi or airlines or pharma or toba=
cco or gutka or any group) cater to only interests of own group.But in=
USA Consumer Healthcare Products Association (CHPA), voluntarily announced=
labelling warnings read on.......</DIV>
<DIV> </DIV>
<DIV>2. Indian / aharashtra FDA does not have such useful informative site =
like FDA USA which gives latest updates for citizens and consumers.</DIV>
<DIV> </DIV>
<DIV>3. Newspapers r busy covering khans, B's , naked,s, promting ladies ba=
rs etc. See the contents of daily newspapers.How many pages are for w=
hat purpose.</DIV>
<DIV> </DIV>
<DIV> </DIV>
<DIV> </DIV>
<DIV> </DIV>
<DIV>
<HR width=3D"50%">
=20
<P><A name=3D7></A><IMG alt=3D" " src=3D"http://www.accessdata.fda.gov/scri=
pts/cdrh/cfdocs/psn/category5.gif" align=3DabsMiddle><FONT size=3D+2><B>Pat=
ients Are Asking</B></FONT></P>
<P>
<TABLE cellSpacing=3D0 cellPadding=3D0 width=3D"100%" border=3D0>
<TBODY>
<TR>
<TD colSpan=3D2 height=3D14><IMG height=3D14 alt=3DJanuary src=3D"http://ww=
w.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/controlpanel-month1.gif"><IMG =
height=3D14 alt=3D2009 src=3D"http://www.accessdata.fda.gov/scripts/cdrh/cf=
docs/psn/controlpanel-year2009.gif" width=3D34><A href=3D"http://www.access=
data.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm"><IMG height=3D14 alt=3D"FDA=
Patient Safety News Homepage" src=3D"http://www.accessdata.fda.gov/scripts=
/cdrh/cfdocs/psn/controlpanel-homelink.gif" border=3D0></A></TD></TR>
<TR>
<TD vAlign=3Dcenter align=3Dmiddle width=3D"100%" background=3Dcontrolpanel=
-frame1.gif><FONT size=3D+1><B>New Labels for Non-prescription Cough and Co=
ld Medications</B></FONT></TD>
<TD align=3Dright><IMG height=3D84 alt=3D"(Video, print, and e-mail functio=
ns)" src=3D"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/controlpa=
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yer Closed Captioned" coords=3D95,38,135,58 href=3D"http://www.connectlive.=
com/events/fdatv/fda-show83-seg7-cc.ram"><AREA shape=3DRECT alt=3D"Windows =
Media Cable/DSL" coords=3D135,15,206,35 href=3D"http://www.connectlive.com/=
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(Right-click and pick 'Save Target As' to save to disk.)" coords=3D95,61,20=
6,81
href=3D"http://www.fda.gov/cdrh/psn/video/mpeg/FDA-SHOW83-SEG7.MPG"><AREA =
shape=3DRECT alt=3D"Print Story" coords=3D209,15,258,44 href=3D"printer.cfm=
?id=3D931"><AREA shape=3DRECT alt=3D"E-mail Story" coords=3D209,52,258,81 h=
ref=3D"mailto:?subject=3DFDA Patient Safety News: New Labels for Non-prescr=
iption Cough and Cold Medications&body=3DThe following story was sent t=
o you from FDA Patient Safety News. To read, visit: http://www.accessdata.f=
da.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=3D83#7"></MAP>
<P>Most makers of nonprescription cough and cold medicines are voluntarily =
changing the labels on these products to say "do not use" for children unde=
r 4 years of age. New child resistant packaging and measuring devices are a=
lso being introduced. <BR><BR>The changes were recently announced by the Co=
nsumer Healthcare Products Association (CHPA), which represents most of the=
se manufacturers. FDA supports this action, which reflects a more restricti=
ve use of these drugs in children.<BR><BR>FDA is working with other public =
health and scientific organizations to obtain, analyze and make available t=
he most up-to-date information about the effects of these medicines on chil=
dren, and FDA will take additional action as needed. In the meantime, here =
are some reminders for parents and caregivers:<BR><BR>=E2=80=A2 First, unde=
rstand that these medicines do not cure a cold or cough or shorten its dura=
tion. They only treat a child's symptom(s) such as a runny nose,
congestion, fever and aches. <BR><BR>=E2=80=A2 Do not give children medica=
tions labeled only for adults.<BR><BR>=E2=80=A2 Choose OTC cough and cold m=
edicines with child-resistant safety caps, where possible. Be sure to close=
the cap tightly after use, and store the medication out of reach of childr=
en.<BR><BR>=E2=80=A2 Check the "Drug Facts" on the label, which tells how m=
uch medicine to give and how often to give it. Misusing or using too much o=
f these products can cause serious and even life threatening side effects s=
uch as rapid heartbeat, drowsiness, suppression of the respiratory system a=
nd seizures. <BR><BR>=E2=80=A2 Be careful when giving a child more than one=
medicine. Using two medicines with the same or similar active ingredients =
could give a child too much of that drug. <BR><BR>=E2=80=A2 Only use measur=
ing devices that come with the medicine, or those specially made for measur=
ing drugs. <BR><BR>=E2=80=A2 Finally, if you have questions or are not sure=
how to use a product, check
with the doctor or pharmacist.<BR></P>
<P><B>Additional Information:</B></P>
<P>FDA MedWatch Safety Alert. Over The Counter Cough and Cold Medications. =
October 9, 2008.<BR><A href=3D"http://www.fda.gov/medwatch/safety/2008/safe=
ty08.htm#CoughCold">http://www.fda.gov/medwatch/safety/2008/safety08..htm#C=
oughCold</A> </P>
<TABLE width=3D"100%" border=3D0>
<TBODY>
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<TD>
<P><A href=3D"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcr=
ipt.cfm?show=3D83#">Return to Top</A></P></TD>
<TD align=3Dright>
<P><A href=3D"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.c=
fm">Return to FDA Patient Safety News Home</A></P></TD></TR></TBODY></TABLE=
>
<HR width=3D"100%" height=3D"1">
<P>FDA Patient Safety News is a product of the US Federal Government, and a=
s such is NOT copyrighted or restricted in any way. We encourage the furthe=
r use and distribution of the video or text of the program by anyone =E2=80=
=93 either in its entirety or as individual stories.</P>
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