children’s allegra allergy 12hr odt alg k 12hr v1 … 41167-4233-3 fexofenadine hcl orally...
TRANSCRIPT
®
Ages 6 Years & Older
fexofenadine HCl orally disintegrating tablet 30 mg/antihistamineIndoor and Outdoor Allergies
NDC 41167-4233-3
®
Ages 6 Years& Older
Hour
®
Ages 6 Years& Older
Hour
Hour
ODTvert-01
Drug FactsActive ingredient (in each tablet) PurposeFexofenadine HCl 30 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Antihistamine
Usestemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:� runny nose � sneezing � itchy, watery eyes � itching of the nose or throat
WarningsDo not use if you have ever had an allergic reaction to this product or any of its ingredients.Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.When using this product� do not take more than directed� do not take at the same time as aluminum or magnesium antacids� do not take with fruit juices (see Directions)
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If 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 away.
Dist. By: Chattem, Inc (partof the sanofi-aventis Group),
Chattanooga, TN37409-0219 ©2012
Directions
Other information� each tablet contains: sodium 5 mg� phenylketonurics: contains phenylalanine 5.3 mg per tablet� safety sealed: do not use if carton is opened or if individual blister units are torn or opened� store between 20° and 25°C (68° and 77°F)� use tablet immediately after opening individual blister
Inactive ingredientsaspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol,methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodiumstarch glycolate
Questions or comments?call toll-free 1-800-633-1610 or www.allegra.com
take 2 tablets every 12 hours on an empty stomach;do not take more than 4 tablets in 24 hours
take 1 tablet every 12 hours on an empty stomach;do not take more than 2 tablets in 24 hours
do not use
ask a doctor
ask a doctor
� place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children12 years of age and over
children 6 to under 12 years of age
children under 6 years of age
adults 65 years of age and older
consumers with kidney disease
The makers of Allegra®do not make store
brand products. Thetrade dress of this
Allegra® package is subject to trademark
protection.
4116742333
02
Relief of:
Runny NoseSneezingItchy, Watery EyesItchy Noseor Throat
orangecream
orangecream
FLAVOR
orangecream
orangecream
FLAVOR
Hour
12 OrallyDisintegratingTablets
OrallyDisintegratingTablets12
®
NON-DROWSY
NON-DROWSY
Dissolves without water
LOT:
EXP:
®
12 OrallyDisintegratingTablets
Hour
TABLETS
Children’s Allegra Allergy 12hr ODTALG_K_12hr_V1_ODTvert-01
6 point Helvetica RegularBody Text:
0.5 point hairline
table format for3 or more doses
left justified, 6.5 leading
14 point Helvetica Bolditalic, left justified
Title:
Right Justified
6 point Helvetica BoldSubheadings:
left justified
Headings:8 point Helvetica Bold
italic, left justified
2.5 point barline
Bullet:5 point
solid square
Reference ID: 3299778
®
Ages 6 Years & Older
fexofenadine HCl orally disintegrating tablet 30 mg/antihistamineIndoor and Outdoor Allergies
NDC 41167-4233-3
®
Ages 6 Years& Older
Hour
®
Ages 6 Years& Older
Hour
Hour
ODTvert-01
Drug FactsActive ingredient (in each tablet) PurposeFexofenadine HCl 30 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Antihistamine
Usestemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:� runny nose � sneezing � itchy, watery eyes � itching of the nose or throat
WarningsDo not use if you have ever had an allergic reaction to this product or any of its ingredients.Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.When using this product� do not take more than directed� do not take at the same time as aluminum or magnesium antacids� do not take with fruit juices (see Directions)
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If 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 away.
Dist. By: Chattem, Inc (partof the sanofi-aventis Group),
Chattanooga, TN37409-0219 ©2012
Directions
Other information� each tablet contains: sodium 5 mg� phenylketonurics: contains phenylalanine 5.3 mg per tablet� safety sealed: do not use if carton is opened or if individual blister units are torn or opened� store between 20° and 25°C (68° and 77°F)� use tablet immediately after opening individual blister
Inactive ingredientsaspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol,methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodiumstarch glycolate
Questions or comments?call toll-free 1-800-633-1610 or www.allegra.com
take 2 tablets every 12 hours on an empty stomach;do not take more than 4 tablets in 24 hours
take 1 tablet every 12 hours on an empty stomach;do not take more than 2 tablets in 24 hours
do not use
ask a doctor
ask a doctor
� place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children12 years of age and over
children 6 to under 12 years of age
children under 6 years of age
adults 65 years of age and older
consumers with kidney disease
The makers of Allegra®do not make store
brand products. Thetrade dress of this
Allegra® package is subject to trademark
protection.
4116742333
02
Relief of:
Runny NoseSneezingItchy, Watery EyesItchy Noseor Throat
orangecream
orangecream
FLAVOR
orangecream
orangecream
FLAVOR
Hour
12 OrallyDisintegratingTablets
OrallyDisintegratingTablets12
®
NON-DROWSY
NON-DROWSY
Dissolves without water
LOT:
EXP:
®
12 OrallyDisintegratingTablets
Hour
Tablets
Reference ID: 3299778
®
Ages 6 Years & Older
fexofenadine HCl orally disintegrating tablet 30 mg/antihistamineIndoor and Outdoor Allergies
NDC 41167-4233-3
®
Ages 6 Years& Older
Hour
®
Ages 6 Years& Older
Hour
Hour
ODTvert-01
Drug FactsActive ingredient (in each tablet) PurposeFexofenadine HCl 30 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Antihistamine
Usestemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:� runny nose � sneezing � itchy, watery eyes � itching of the nose or throat
WarningsDo not use if you have ever had an allergic reaction to this product or any of its ingredients.Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.When using this product� do not take more than directed� do not take at the same time as aluminum or magnesium antacids� do not take with fruit juices (see Directions)
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If 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 away.
Dist. By: Chattem, Inc (partof the sanofi-aventis Group),
Chattanooga, TN37409-0219 ©2012
Directions
Other information� each tablet contains: sodium 5 mg� phenylketonurics: contains phenylalanine 5.3 mg per tablet� safety sealed: do not use if carton is opened or if individual blister units are torn or opened� store between 20° and 25°C (68° and 77°F)� use tablet immediately after opening individual blister
Inactive ingredientsaspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol,methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodiumstarch glycolate
Questions or comments?call toll-free 1-800-633-1610 or www.allegra.com
take 2 tablets every 12 hours on an empty stomach;do not take more than 4 tablets in 24 hours
take 1 tablet every 12 hours on an empty stomach;do not take more than 2 tablets in 24 hours
do not use
ask a doctor
ask a doctor
� place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children12 years of age and over
children 6 to under 12 years of age
children under 6 years of age
adults 65 years of age and older
consumers with kidney disease
The makers of Allegra®do not make store
brand products. Thetrade dress of this
Allegra® package is subject to trademark
protection.
4116742333
02
Relief of:
Runny NoseSneezingItchy, Watery EyesItchy Noseor Throat
orangecream
orangecream
FLAVOR
orangecream
orangecream
FLAVOR
Hour
12 OrallyDisintegratingTablets
OrallyDisintegratingTablets12
®
NON-DROWSY
NON-DROWSY
Dissolves without water
LOT:
EXP:
®
12 OrallyDisintegratingTablets
Hour
Tablets
Reference ID: 3299778
Reference ID: 3299778
NDC 41167-4233-3
fexofenadine HCl orally disintegrating tablet 30 mg/antihistamineIndoor and Outdoor Allergies
NON-DROWSY
12Orally DisintegratingTablets
Relief of:
Runny NoseSneezingItchy, Watery EyesItchy Nose or Throat
Hour
Dissolves without water
Hour
®
12Orally DisintegratingTablets
18
NON-DROWSY
18
LOT
EXP®
®
Ages
6 Y
ears
& O
lder
Hou
r
The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection.
Ages 6 Years & Older
®
Ages 6 Years & Older
BAR CODEFPO
orangecream
orangecream
FLAVOR
0044961-01
Drug FactsActive ingredient (in each tablet) PurposeFexofenadine HCl 30 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Antihistamine
Usestemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:� runny nose � itchy, watery eyes� sneezing � itching of the nose or throat
WarningsDo not use if you have ever had an allergic reaction to this product or any of its ingredients.Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.When using this product� do not take more than directed� do not take at the same time as aluminum or magnesium antacids� do not take with fruit juices (see Directions)
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If 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 away.
Drug Facts (continued)Directions� place 1 tablet on tongue; tablet disintegrates, with or without water adults and children take 2 tablets every 12 hours on 12 years of age and over an empty stomach; do not take more than 4 tablets in 24 hours children 6 to under take 1 tablet every 12 hours on 12 years of age an empty stomach; do not take more than 2 tablets in 24 hours children under 6 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
Other information� each tablet contains: sodium 5 mg� phenylketonurics: contains phenylalanine 5.3 mg per tablet� safety sealed: do not use if carton is opened or if individual blister units are torn or opened� store between 20° and 25°C (68° and 77°F)� use tablet immediately after opening individual blister
Inactive ingredientsaspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodium starch glycolate
Questions or comments?call toll-free 1-800-633-1610 or www.allegra.com
�
Dist. By: Chattem, Inc.(part of the sanofi-aventis Group),Chattanooga, TN 37409-0219 ©2012
BONUS!6FREE
Orally DisintegratingTablets
®
Children’s Allegra Oral Dissentegrating Tablets- BONUS CTNALG_12hrODT_18ctBonus_CTN
6 point Helvetica RegularBody Text:
0.5 point hairline
left justified, 6.5 leading
14 point Helvetica Bolditalic, left justified
Title:
Right Justified
Headings:8 point Helvetica Bold
italic, left justified
Bullet:5 point
solid square
8 point Helvetica Bold ItalicTitle for Continued Panel:
6 point Helvetica BoldSubheadings:
left justified
Graphic leadingto next panel
table format for3 or more doses
2.5 point barline
Reference ID: 3299778
NDC 41167-4233-3
fexofenadine HCl orally disintegrating tablet 30 mg/antihistamineIndoor and Outdoor Allergies
NON-DROWSY
12 Orally DisintegratingTablets
Relief of:
Runny NoseSneezingItchy, Watery EyesItchy Nose or Throat
Hour
Dissolves without water
Hour
®
12 Orally DisintegratingTablets
18
NON-DROWSY
18
LOT
EXP
®
®
Ages 6 Years & O
lder
Hour
The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection.
Ages 6 Years & Older
®
Ages 6 Years & Older
BAR CODEFPO
orangecream
orangecream
FLAVOR
0044961-01
Drug FactsActive ingredient (in each tablet) PurposeFexofenadine HCl 30 mg................................Antihistamine
Usestemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:� runny nose � itchy, watery eyes� sneezing � itching of the nose or throat
WarningsDo not use if you have ever had an allergic reaction to this product or any of its ingredients.Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.When using this product� do not take more than directed� do not take at the same time as aluminum or magnesium antacids� do not take with fruit juices (see Directions)
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If 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 away.
Drug Facts (continued)Directions� place 1 tablet on tongue; tablet disintegrates, with or without water adults and children take 2 tablets every 12 hours on 12 years of age and over an empty stomach; do not take more than 4 tablets in 24 hours children 6 to under take 1 tablet every 12 hours on 12 years of age an empty stomach; do not take more than 2 tablets in 24 hours children under 6 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
Other information� each tablet contains: sodium 5 mg� phenylketonurics: contains phenylalanine 5.3 mg per tablet� safety sealed: do not use if carton is opened or if individual blister units are torn or opened� store between 20° and 25°C (68° and 77°F)� use tablet immediately after opening individual blister
Inactive ingredientsaspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodium starch glycolate
Questions or comments?call toll-free 1-800-633-1610 or www.allegra.com
�
Dist. By: Chattem, Inc.(part of the sanofi-aventis Group),Chattanooga, TN 37409-0219 ©2012
BONUS!6FREEOrally Disintegrating
Tablets
®
Reference ID: 3299778
NDC 41167-4233-3
fexofenadine HCl orally disintegrating tablet 30 mg/antihistamineIndoor and Outdoor Allergies
NON-DROWSY
12 Orally DisintegratingTablets
Relief of:
Runny NoseSneezingItchy, Watery EyesItchy Nose or Throat
Hour
Dissolves without water
Hour
®
12 Orally DisintegratingTablets
18
NON-DROWSY
18
LOT
EXP
®
®
Ages 6 Years & O
lder
Hour
The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection.
Ages 6 Years & Older
®
Ages 6 Years & Older
BAR CODEFPO
orangecream
orangecream
FLAVOR
0044961-01
Drug FactsActive ingredient (in each tablet) PurposeFexofenadine HCl 30 mg................................Antihistamine
Usestemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:� runny nose � itchy, watery eyes� sneezing � itching of the nose or throat
WarningsDo not use if you have ever had an allergic reaction to this product or any of its ingredients.Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.When using this product� do not take more than directed� do not take at the same time as aluminum or magnesium antacids� do not take with fruit juices (see Directions)
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If 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 away.
Drug Facts (continued)Directions� place 1 tablet on tongue; tablet disintegrates, with or without water adults and children take 2 tablets every 12 hours on 12 years of age and over an empty stomach; do not take more than 4 tablets in 24 hours children 6 to under take 1 tablet every 12 hours on 12 years of age an empty stomach; do not take more than 2 tablets in 24 hours children under 6 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
Other information� each tablet contains: sodium 5 mg� phenylketonurics: contains phenylalanine 5.3 mg per tablet� safety sealed: do not use if carton is opened or if individual blister units are torn or opened� store between 20° and 25°C (68° and 77°F)� use tablet immediately after opening individual blister
Inactive ingredientsaspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodium starch glycolate
Questions or comments?call toll-free 1-800-633-1610 or www.allegra.com
�
Dist. By: Chattem, Inc.(part of the sanofi-aventis Group),Chattanooga, TN 37409-0219 ©2012
BONUS!6FREEOrally Disintegrating
Tablets
®
Reference ID: 3299778
14 pointAbadi ExtraBold
6 pointAbadi Light
14 pointAbadi ExtraBold
5 pointAbadi Light
11 pointAbadi ExtraBold
7 pointHelvetica Condensed
11 pointAbadi ExtraBold
9 pointAgenda Bold
9 pointAgenda Medium
6 pointAgenda Medium
Children’s Allegra Oral Dissentegrating TabletsVERTICAL BLISTER
ALG_K 12hr_BLI_ODTvert
ODTvertBLI-01
PEEL
PEEL PEEL
PEEL
PEEL
PEEL PEEL
PEEL
Lot 00000000 Exp M
M/Y
YY
Y
Lot 00000000 Exp M
M/Y
YY
YLot 00000000 E
xp MM
/YY
YY
Lot 00000000 Exp M
M/Y
YY
Y
Lot 00000000 Exp M
M/Y
YY
Y
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Lot 00000000 Exp M
M/Y
YY
Y
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Reference ID: 3299778
ODTvertBLI-01
PEEL
PEEL PEEL
PEEL
PEEL
PEEL PEEL
PEEL
Lot 00000000 Exp M
M/Y
YY
Y
Lot 00000000 Exp M
M/Y
YY
YLot 00000000 E
xp MM
/YY
YY
Lot 00000000 Exp M
M/Y
YY
Y
Lot 00000000 Exp M
M/Y
YY
Y
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Lot 00000000 Exp M
M/Y
YY
Y
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Reference ID: 3299778
ODTvertBLI-01
PEEL
PEEL PEEL
PEEL
PEEL
PEEL PEEL
PEEL
Lot 00000000 Exp M
M/Y
YY
Y
Lot 00000000 Exp M
M/Y
YY
YLot 00000000 E
xp MM
/YY
YY
Lot 00000000 Exp M
M/Y
YY
Y
Lot 00000000 Exp M
M/Y
YY
Y
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Lot 00000000 Exp M
M/Y
YY
Y
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Dist. By: Chattem, Inc.Chattanooga, TN 37409-0219
fexofenadine HCI 30 mgorally disintegrating tablets
Children’s
AllergyAll gra®
12 Hour
TEAR AT PERFORATION PEEL AT CORNER
Reference ID: 3299778
---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------
JOEL SCHIFFENBAUER04/28/2013
Reference ID: 3299778