Document 62639
Children’s Allegra Allergy 12hr ODT ALG_K_12hr_V1_ODTvert-01 NON-DROWSY ® 12 Ages 6 Years & Older Hour Orally Disintegrating Tablets NON-DROWSY NDC 41167-4233-3 Hour ® ® ® Drug Facts Active ingredient (in each tablet) Purpose Fexofenadine HCl 30 mg ............................................................Antihistamine Ages 6 Years & Older ® Ages 6 Years & Older Hour Hour fexofenadine HCl orally disintegrating tablet 30 mg/antihistamine Indoor and Outdoor Allergies Dist. By: Chattem, Inc (part of the sanofi-aventis Group), Chattanooga, TN 37409-0219 ©2012 orange cream TABLETS FLAVOR 0 Orally Disintegrating Tablets Hour Relief of: Runny Nose Sneezing Itchy, Watery Eyes Itchy Nose or Throat cream FLAVOR 12 Dissolves without water LOT: EXP: Reference ID: 3299778 orange Orally Disintegrating Tablets 2 ODTvert-01 Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat Warnings Do 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. Directions place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 12 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 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 Other information 41167 42333 12 The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection. 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 ingredients aspartame, 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 Title: 14 point Helvetica Bold italic, left justified Right Justified Headings: 8 point Helvetica Bold italic, left justified Body Text: 6 point Helvetica Regular left justified, 6.5 leading Subheadings: 6 point Helvetica Bold left justified 0.5 point hairline table format for 3 or more doses Bullet: 5 point solid square 2.5 point barline The carton orientation at Point of Sale (on store shelf) changed from horizontal to vertical The Proprietary Name, established name/dosage all centered on the PDP Added name and 12Hour designation on rear panel Format of the Drug Facts changed to a single column from two columns; no language was changed NON-DROWSY The 12Hour designation repositioned from right side of top panel ® 12 Ages 6 Years & Older Hour Orally Disintegrating Tablets NON-DROWSY NDC 41167-4233-3 Hour ® ® ® Drug Facts Active ingredient (in each tablet) Purpose Fexofenadine HCl 30 mg ............................................................Antihistamine Ages 6 Years & Older ® Ages 6 Years & Older Hour The Proprietary Name and age designation now oriented in a stacked manner to accommodate narrower side panels Hour fexofenadine HCl orally disintegrating tablet 30 mg/antihistamine Indoor and Outdoor Allergies Dist. By: Chattem, Inc (part of the sanofi-aventis Group), Chattanooga, TN 37409-0219 ©2012 orange cream Tablets FLAVOR Orally Disintegrating Tablets Hour Relief of: Runny Nose Sneezing Itchy, Watery Eyes Itchy Nose or Throat orange cream FLAVOR 12 Orally Disintegrating Tablets 2 ODTvert-01 Dissolves without water Switched the LOT: order of Added a depiction of a "Runny Nose" and EXP: tablet along with the word "Sneezing" to be "Tablets" to aid in consistent with the entire identifying the dosage form line and the approved PDP for the Allegra Repositioned "Dissolves Allergy labeling without water" Reference ID: 3299778 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat Warnings Do 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. Directions place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 12 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 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 Other information 41167 42333 Flavor designation and depiction and Net Quantity of Contents added to side panel 0 12 The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection. Uses 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 ingredients aspartame, 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 NON-DROWSY ® 12 Ages 6 Years & Older Hour Orally Disintegrating Tablets NON-DROWSY NDC 41167-4233-3 Hour ® ® ® Drug Facts Active ingredient (in each tablet) Purpose Fexofenadine HCl 30 mg ............................................................Antihistamine Ages 6 Years & Older ® Ages 6 Years & Older Hour Hour fexofenadine HCl orally disintegrating tablet 30 mg/antihistamine Indoor and Outdoor Allergies Dist. By: Chattem, Inc (part of the sanofi-aventis Group), Chattanooga, TN 37409-0219 ©2012 orange cream Tablets FLAVOR 0 Orally Disintegrating Tablets Hour Relief of: Runny Nose Sneezing Itchy, Watery Eyes Itchy Nose or Throat cream FLAVOR 12 Dissolves without water LOT: EXP: Reference ID: 3299778 orange Orally Disintegrating Tablets 2 ODTvert-01 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat Warnings Do 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. Directions place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 12 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 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 Other information 41167 42333 12 The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection. Uses 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 ingredients aspartame, 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 Children's Orally Disintegrating Tablets 3-D Carton Rendering With Dimensions Carton Width 2⅞ in. Carton 5⅛ in. Height Reference ID: 3299778 Carton Depth ⅞ in. Children’s Allegra Oral Dissentegrating Tablets- BONUS CTN ALG_12hrODT_18ctBonus_CTN Ages 6 Years & Older ® The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection. Dissolves without water Hour Indoor and Outdoor Allergies Orally Disintegrating 12 18 Tablets fexofenadine HCl orally disintegrating tablet 30 mg/antihistamine Runny Nose Sneezing Itchy, Watery Eyes Itchy Nose or Throat FLAVOR cream orange Relief of: ® Hour ® NDC 41167-4233-3 Orally Disintegrating 6 FREE Tablets BONUS! NON-DROWSY Hour ® Orally Disintegrating 12 18 Tablets Ages 6 Years & Older ® NON-DROWSY Title: 14 point Helvetica Bold italic, left justified Drug Facts Active ingredient (in each tablet) Purpose Fexofenadine HCl 30 mg ................................Antihistamine Uses Headings: 8 point Helvetica Bold italic, left justified Bullet: 5 point solid square 0.5 point hairline Subheadings: 6 point Helvetica Bold left justified temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat Warnings Do 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.(part of the sanofi-aventis Group), Chattanooga, TN 37409-0219 ©2012 0044961-01 Drug Facts (continued) Directions Title for Continued Panel: 8 point Helvetica Bold Italic place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 12 years of age and over take 2 tablets every 12 hours on 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 table format for 3 or more doses Body Text: 6 point Helvetica Regular left justified, 6.5 leading store between 20° and 25°C (68° and 77°F) use tablet immediately after opening individual blister Inactive ingredients aspartame, 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 Graphic leading to next panel Reference ID: 3299778 Ages 6 Years & Older BAR CODE FPO LOT EXP Right Justified 2.5 point barline Reference ID: 3299778 Repositioned "Dissolves without BAR CODE water" from FPObottom Ages 6 Years & Older left of carton The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection. Dissolves without water EXP Disintegrating 12 18 Orally Tablets FLAVOR cream orange LOT Indoor and Outdoor Allergies fexofenadine HCl orally disintegrating tablet 30 mg/antihistamine Runny Nose Sneezing Itchy, Watery Eyes Itchy Nose or Throat Relief of: Hour ® Net Quantity of Contents necessarily changed Switched the order of "Runny Nose" and "Sneezing" to be consistent with the entire line and the approved PDP for Allegra Allergy labeling ® NDC number repositioned to allow for the Bonus flag NDC 41167-4233-3 Disintegrating 6 FREE Orally Tablets ® Ages 6 Years & Older Hour ® Bonus flag added BONUS! The 12Hour designation repositioned from right side of top panel NON-DROWSY Hour Disintegrating 12 18 Orally Tablets Ages 6 Years & Older Removed "Original Prescription Strength" and repositioned "NON-DROWSY" accordingly Net Quantity of Contents necessarily changed ® Removed "Original Prescription Strength" and repositioned "NONDROWSY" accordingly NON-DROWSY Drug Facts Active ingredient (in each tablet) Drug Facts (continued) Directions Purpose Fexofenadine HCl 30 mg ................................Antihistamine Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: itchy, watery eyes itching of the nose or throat runny nose sneezing Warnings Do 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 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 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) units are torn or opened store between 20° and 25°C (68° and 77°F) use tablet immediately after opening individual blister Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. Inactive ingredients 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 0044961-01 aspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodium starch glycolate 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. Questions or comments? No change to any of the approved Drug Facts language or formatting Reference ID: 3299778 Ages 6 Years & Older The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection. BAR CODE FPO Dissolves without water EXP LOT Disintegrating 12 18 Orally Tablets FLAVOR cream orange Hour ® ® Ages 6 Years & Older Hour ® Indoor and Outdoor Allergies fexofenadine HCl orally disintegrating tablet 30 mg/antihistamine Runny Nose Sneezing Itchy, Watery Eyes Itchy Nose or Throat Relief of: ® NDC 41167-4233-3 Disintegrating 6 FREE Orally Tablets BONUS! NON-DROWSY Hour Disintegrating 12 18 Orally Tablets Ages 6 Years & Older ® NON-DROWSY Drug Facts Active ingredient (in each tablet) Drug Facts (continued) Directions Purpose Fexofenadine HCl 30 mg ................................Antihistamine Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: itchy, watery eyes itching of the nose or throat runny nose sneezing Warnings Do 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 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 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) units are torn or opened store between 20° and 25°C (68° and 77°F) use tablet immediately after opening individual blister Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. Inactive ingredients 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 0044961-01 aspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodium starch glycolate 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. Questions or comments? Children’s Allegra Oral Dissentegrating Tablets VERTICAL BLISTER ALG_K 12hr_BLI_ODTvert Children’s fexofenadine HCI 30 mg orally disintegrating tablets 14 point Abadi ExtraBold 12 Hour Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 Lot 00000000 Exp MM/YYYY Allergy Children’s Lot 00000000 Exp MM/YYYY All gra ® TEAR AT PERFORATION PEEL AT CORNER EL EL ODTvertBLI-01 Allergy fexofenadine HCI 30 mg orally disintegrating tablets Reference ID: 3299778 12 Hour Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 TEAR AT PERFORATION PEEL AT CORNER ® Allergy fexofenadine HCI 30 mg orally disintegrating tablets 12 Hour 11 point Abadi ExtraBold 9 point Agenda Bold Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 TEAR AT PERFORATION PEEL AT CORNER EL Lot 00000000 Exp MM/YYYY ® Lot 00000000 Exp MM/YYYY All gra 5 point Abadi Light PE EL Children’s EL 6 point Agenda Medium EL TEAR AT PERFORATION PEEL AT CORNER All gra PE Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 PE 12 Hour PE Allergy fexofenadine HCI 30 mg orally disintegrating tablets Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 Children’s Lot 00000000 Exp MM/YYYY 9 point Agenda Medium 12 Hour EL Lot 00000000 Exp MM/YYYY ® Allergy fexofenadine HCI 30 mg orally disintegrating tablets PE PE PE EL All gra 11 point Abadi ExtraBold TEAR AT PERFORATION PEEL AT CORNER PE Children’s All gra ® Children’s All gra ® Allergy fexofenadine HCI 30 mg orally disintegrating tablets 7 point Helvetica Condensed 14 point Abadi ExtraBold 12 Hour Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 TEAR AT PERFORATION PEEL AT CORNER 6 point Abadi Light Children’s 12 Hour Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 Lot 00000000 Exp MM/YYYY Allergy fexofenadine HCI 30 mg orally disintegrating tablets Children’s Lot 00000000 Exp MM/YYYY All gra ® TEAR AT PERFORATION PEEL AT CORNER EL EL PE EL 12 Hour Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 TEAR AT PERFORATION PEEL AT CORNER ® Allergy fexofenadine HCI 30 mg orally disintegrating tablets 12 Hour Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 TEAR AT PERFORATION PEEL AT CORNER EL Lot 00000000 Exp MM/YYYY Allergy fexofenadine HCI 30 mg orally disintegrating tablets Lot 00000000 Exp MM/YYYY All gra ® EL Children’s Reference ID: 3299778 EL ODTvertBLI-01 All gra PE TEAR AT PERFORATION PEEL AT CORNER PE 12 Hour Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 PE Allergy fexofenadine HCI 30 mg orally disintegrating tablets Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 Children’s Lot 00000000 Exp MM/YYYY ® 12 Hour EL Lot 00000000 Exp MM/YYYY All gra Allergy fexofenadine HCI 30 mg orally disintegrating tablets PE PE PE EL The blister orientation is now vertical to align with the proposed orientation of the carton ® TEAR AT PERFORATION PEEL AT CORNER PE Children’s All gra Children’s All gra ® Allergy fexofenadine HCI 30 mg orally disintegrating tablets 12 Hour Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 TEAR AT PERFORATION PEEL AT CORNER Proprietary name is stacked on 3 lines instead of 2, and words are centered Children’s 12 Hour Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 Lot 00000000 Exp MM/YYYY Allergy fexofenadine HCI 30 mg orally disintegrating tablets Children’s Lot 00000000 Exp MM/YYYY All gra ® TEAR AT PERFORATION PEEL AT CORNER EL EL EL EL 12 Hour Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 TEAR AT PERFORATION PEEL AT CORNER ® Allergy fexofenadine HCI 30 mg orally disintegrating tablets 12 Hour Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 TEAR AT PERFORATION PEEL AT CORNER EL Lot 00000000 Exp MM/YYYY Allergy fexofenadine HCI 30 mg orally disintegrating tablets Lot 00000000 Exp MM/YYYY All gra ® Reference ID: 3299778 PE EL Children’s All gra PE ODTvertBLI-01 PE TEAR AT PERFORATION PEEL AT CORNER PE 12 Hour Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 Children’s Lot 00000000 Exp MM/YYYY Allergy fexofenadine HCI 30 mg orally disintegrating tablets 12 Hour EL Lot 00000000 Exp MM/YYYY ® Allergy fexofenadine HCI 30 mg orally disintegrating tablets PE PE PE EL All gra ® TEAR AT PERFORATION PEEL AT CORNER PE Children’s All gra Children’s All gra ® Allergy fexofenadine HCI 30 mg orally disintegrating tablets 12 Hour Dist. By: Chattem, Inc. Chattanooga, TN 37409-0219 TEAR AT PERFORATION PEEL AT CORNER --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------/s/ ---------------------------------------------------JOEL SCHIFFENBAUER 04/28/2013 Reference ID: 3299778
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