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MONTELUKAST PAEDIATRIC 5MG CHEWABLE TABLETS

Active substance(s): MONTELUKAST SODIUM

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Transcript
VAR. # 2 add 'Paediatric' to name
Approved by H.Udani on 2.7.08

CARTON LABEL

LABEL SIZE 4CM X 8CM
SINGULAIR® PAEDIATRIC 5MG CHEWABLE TABLETS (montelukast sodium)
28 TABLETS
Each tablet contains 5mg montelukast (as montelukast sodium). Also includes
aspartame equivalent to 0.842mg phenylalanine. Please read enclosed leaflet
before use. Take by mouth. The tablets are to be chewed, as directed by a
medical practitioner. Take one hour before, or two hours after food. Usual dosage
(age 6-14 years): 1 tablet daily at bed time. Do not store above 30°C. Store in the
original container to protect from moisture and light.
POM
KEEP OUT OF THE REACH & SIGHT OF CHILDREN.
Manufactured by: Merck Sharp & Dohme Ltd, Northumberland, UK. Procured from
within the EU and repackaged by the Product Licence Holder: B&S Healthcare,
Unit 7, Crystal Way, Elmgrove Road, Harrow, Middlesex HA1 2HP.
PL No: 18799/0962 ECMA: 034001026 Batch No:
Exp:

BLISTER LABEL
LABEL SIZE: 7.5CM X 1.3CM
MON

TUE

WED

THU

SINGULAIR® PAEDIATRIC 5MG CHEWABLE TABLETS (montelukast sodium)

B&S Healthcare, Harrow, Middlesex
FRI
SAT

END OF PACK LABEL

LABEL SIZE: 1CM X 3CM
SINGULAIR® PAEDIATRIC 5MG
CHEWABLE TABLETS
(montelukast sodium)
28 tablets

Batch:
SUN

Exp:

06.11.2007
CARTON LABEL

LABEL SIZE 4CM X 8CM
MONTELUKAST PAEDIATRIC 5MG CHEWABLE TABLETS (montelukast
sodium)28 TABLETS
Each tablet contains 5mg montelukast (as montelukast sodium). Also includes
aspartame equivalent to 0.842mg phenylalanine. Please read enclosed leaflet
before use. Take by mouth. The tablets are to be chewed, as directed by a
medical practitioner. Take one hour before, or two hours after food. Usual dosage
(age 6-14 years): 1 tablet daily at bed time. Do not store above 30°C. Store in the
original container to protect from moisture and light.
POM
KEEP OUT OF THE REACH & SIGHT OF CHILDREN.
Manufactured by: Merck Sharp & Dohme Ltd, Northumberland, UK. Procured from
within the EU and repackaged by the Product Licence Holder: B&S Healthcare,
Unit 7, Crystal Way, Elmgrove Road, Harrow, Middlesex HA1 2HP.
PL No: 18799/0962 ECMA: 034001026 Batch No:
Exp:

BLISTER LABEL
LABEL SIZE: 7.5CM X 1.3CM
MON

TUE

WED

THU

SINGULAIR® PAEDIATRIC 5MG CHEWABLE TABLETS (montelukast sodium)

B&S Healthcare, Harrow, Middlesex
FRI
SAT

END OF PACK LABEL

LABEL SIZE: 1CM X 3CM
SINGULAIR® PAEDIATRIC 5MG
CHEWABLE TABLETS
(montelukast sodium)
28 tablets

Batch:
SUN

Exp:

06.11.2007
OUTER CARTON LABEL

LABEL SIZE: 8CM X 4CM

MONTELUKAST PAEDIATRIC 5MG CHEWABLE TABLETS (montelukast sodium)

28 TABLETS
Each tablet contains 5mg montelukast (as montelukast sodium). Also includes
aspartame equivalent to 0.842mg phenylalanine. Please read enclosed leaflet
before use. Take by mouth. The tablets are to be chewed, as directed by a
medical practitioner. Take one hour before, or two hours after food. Usual dosage
(age 6-14 years): 1 tablet daily at bed time. Do not store above 30°C. Store in the
original container to protect from moisture and light.
KEEP OUT OF THE REACH OF CHILDREN.
Manufactured by: Merck Sharp & Dohme Ltd, Northumberland, UK. Procured from
withinthe EU and repackaged by the Product Licence Holder: B&S Healthcare, Unit
7, Crystal Way, Elmgrove Road, Harrow, Middlesex HA1 2HP.
PL No: 18799/0963 ECMA: 034003020 Batch No:
Exp:

BLISTER LABEL
LABEL SIZE: 7.5CM X 1.3CM
MON

TUE

WED

THU

MONTELUKAST PAEDIATRIC 5MG CHEWABLE TABLETS (montelukast sodium)

B&S Healthcare, Harrow, Middlesex
FRI
SAT

END OF PACK LABEL

LABEL SIZE: 1CM X 3CM
MONTELUKAST PAEDIATRIC 5MG
CHEWABLE TABLETS
(montelukast sodium)
28 tablets

Batch:
SUN

Exp:

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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