children's zyrtec allergy (label) · indoor & outdoor allergies cetirizine hcl allergy 1...

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® Grape Syrup Grape Syrup Grape Syrup ALLERGY Cetirizine HCl 1 mg / ml oral solution a ntihistamine Cetirizine HCl 1 mg /ml oral solution antihistamine Indoor & Outdoor Allergies Dye-Free • Sugar-Free Dye-Free • Sugar-Free Dosing Cup Included Dosing Cup Included Dosing cup should be washed and left to air dry after each use. The trade dress of this ZYRTEC® package is subject to trademark protection. ® Indoor & Outdoor Allergies Dye-Free • Sugar-Free Dye-Free • Sugar-Free Grape Syrup Grape Syrup Grape Syrup ALLERGY Cetirizine HCl 1 mg / ml oral solution a ntihistamine Cetirizine HCl 1 mg /ml oral solution antihistamine ® Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 24 hour Indoor & Outdoor Allergies 4 fl oz (118 ml) 4 fl oz (118 ml) Dosing Cup Included yrs. & older 2 Dye-Free • Sugar-Free Dye-Free • Sugar-Free Grape Syrup Grape Syrup Grape Syrup Grape Syrup ALLERGY Cetirizine HCl 1 mg / ml oral solution t Cetirizine HCl 1 mg /ml oral solution antihistamine Distributed by: McNeil Consumer Healthcare Division of McNEIL-PPC, INC. Fort Washington, PA 19034 USA ©McNEIL-PPC, INC. 2013 www.zyrtec.com 00000000 Drug Facts Drug Facts (continued) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professiona before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Cont ol Center right away. (1-800-222-1222) Ask a doctor before use if you have liver or kidney disease. Your doctor should dete mine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase d owsiness be careful when driving a motor vehicle or operating machinery Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hyd oxyzine. Active ingredient Purpose (in each 5 mL) Cetirizine HCl 5mg.....................................Antihistamine 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 Other information store between 20° to 25°C (68° to 77°F) do not use if carton is opened or if carton tape or bottle wrap imprinted "SAFETY SEAL®" is broken or missing see bottom panel for lot number and expiration date Inactive ingredients anhyd ous citric acid, flavors, propylene glycol, purified water, sodium benzoate, so bitol solution, sucralose adults and children 6 years and over children 2 to under 6 years of age children under 2 years of age adults 65 years and over ask a doctor consumers with liver or kidney disease ask a doctor 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. 5 mL once daily; do not take more than 5 mL in 24 hours. 2 5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. Directions use only with enclosed dosing cup find right dose on chart below mL = milliliter Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect). 3 0045-0209-04 7 LOT: EXP: USA 000000 905 NDC 50580-730-05 NDC 50580-730-05 Reference ID: 3506951 (b) (4)

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Page 1: Children's Zyrtec Allergy (Label) · Indoor & Outdoor Allergies Cetirizine HCl ALLERGY 1 mg /ml oral solution antihistamine 9nZ";gZZ Hj\Vg";gZZ Bubble Gum Syrup ® Relief of Sneezing

®

GrapeSyrupGrapeSyrupGrapeSyrup

ALLERGYCetirizine HCl 1 mg /ml oral solution antihistamine

Cetirizine HCl 1 mg /ml oral solution antihistamine

Indoor & Outdoor Allergies

Dye-Free • Sugar-FreeDye-Free • Sugar-Free

Dosing Cup IncludedDosing Cup Included

Dosing cup should be washed and left to air dry after each use.

The trade dress of this ZYRTEC® package is subject totrademark protection.

®

Indoor & Outdoor Allergies

Dye-Free • Sugar-FreeDye-Free • Sugar-Free

GrapeSyrupGrapeSyrupGrapeSyrup

ALLERGYCetirizine HCl 1 mg /ml oral solution antihistamine

Cetirizine HCl 1 mg /ml oral solution antihistamine

®

Relief of• Sneezing• Runny Nose• Itchy, Watery Eyes• Itchy Throat or Nose

24hour

Indoor & Outdoor Allergies

4 fl oz (118 ml)4 fl oz (118 ml) Dosing Cup Included

yrs.& older2

Dye-Free • Sugar-FreeDye-Free • Sugar-Free

GrapeSyrupGrapeSyrupGrapeSyrupGrapeSyrup

ALLERGYCetirizine HCl 1 mg /ml oral solution t

Cetirizine HCl 1 mg /ml oral solution antihistamine

Distributed by:McNeil Consumer HealthcareDivision of McNEIL-PPC, INC.Fort Washington, PA 19034 USA©McNEIL-PPC, INC. 2013 www.zyrtec.com00000000

Drug Facts Drug Facts (continued)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:� if breast-feeding: not recommended� if pregnant: ask a health professiona before use.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Cont ol Center right away. (1-800-222-1222)

Ask a doctor before use if you have liver or kidney disease. Your doctor should dete mine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product� drowsiness may occur� avoid alcoholic drinks� alcohol, sedatives, and tranquilizers may increase d owsiness� be careful when driving a motor vehicle or operating machinery

WarningsDo not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hyd oxyzine.

Active ingredient Purpose(in each 5 mL) Cetirizine HCl 5mg.....................................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

Other information � store between 20° to 25°C (68° to 77°F)� do not use if carton is opened or if carton tape or bottle wrap imprinted "SAFETY SEAL®" is broken or missing� see bottom panel for lot number and expiration date

Inactive ingredientsanhyd ous citric acid, flavors, propylene glycol, purified water, sodium benzoate, so bitol solution, sucralose

adults and children6 years and over

children 2 to under6 years of age

children under2 years of age

adults 65 yearsand over

ask a doctor

consumers withliver or kidneydisease

ask a doctor

5 mL or 10 mL once daily depending upon severity ofsymptoms; do not take more than 10 mL in 24 hours.

5 mL once daily; do not take more than 5 mL in 24 hours.

2 5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.

Directions � use only with enclosed dosing cup � find right dose on chart below� mL = milliliter

Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect).

3 0045-0209-047

LOT:

EXP:

USA000000

905

NDC 50580-730-05 NDC 50580-730-05

Reference ID: 3506951

(b) (4)

Page 2: Children's Zyrtec Allergy (Label) · Indoor & Outdoor Allergies Cetirizine HCl ALLERGY 1 mg /ml oral solution antihistamine 9nZ";gZZ Hj\Vg";gZZ Bubble Gum Syrup ® Relief of Sneezing

Dosing cup should be washed and left to air dry after each use.

ALLERGYCetirizine HCl 1 mg /ml oral solution antihistamine

Cetirizine HCl 1 mg /ml oral solution antihistamine

Relief of• Sneezing • Runny Nose• Itchy, Watery Eyes• Itchy Throat or Nose

4 fl oz (118 ml)

Indoor & OutdoorAllergies

& older2yrs.

GrapeSyrupGrapeSyrup

Dye-Free • Sugar-FreeDye-Free • Sugar-Free

®

Active ingredient (in each 5 mL) Purpose C tirizine HCl mg…………………………............. AntihistamineUses temporar ly re ieves these symptoms due to hay fever or other upper respiratory allergies: � runny nose � sneezing � itchy, watery eyes � itching of the nose or throatWarnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product � drowsiness may occur � avoid alcoholic drinks � alcohol, sedatives, and tranquilizers may increase drowsiness � be careful when driving a motor vehicle or operating machineryStop use and ask a doctor if an a lergic reaction to this product occurs. Seek medical help right away.If pregnant or breast-feeding: � if breast-feeding: not recommended � if pregnant: 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. (1-800-222-1222)Directions � use only with enclosed dosing cup � mL = milliliter� 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. � adults 65 years and over: 5 mL once daily; do not take more than 5 mL in 24 hours. � children 2 to under 6 years of age: 2 5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2 5 mL every 12 hours. Do not give more than 5 mL in 24 hours.� children under 2 years of age: ask a doctor � consumers with liver or kidney disease: ask a doctor Other information � store between 20° to 25°C (68° to 77°F)� do not use if bottle wrap imprinted “SAFETY SEAL®” is broken or missingInactive ingredients anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate, sorbitol solu ion, sucralose Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect).

Distr buted by: McNe l Consumer HealthcareDivision of McNEIL-PPC, INC., Fort Washington, PA 19034 USA©McNEIL-PPC, INC. 20 3 www.zyrtec.com 00000000

NDC 50580-730-05

Reference ID: 3506951

(b) (4)

Page 3: Children's Zyrtec Allergy (Label) · Indoor & Outdoor Allergies Cetirizine HCl ALLERGY 1 mg /ml oral solution antihistamine 9nZ";gZZ Hj\Vg";gZZ Bubble Gum Syrup ® Relief of Sneezing

®

ALLERGYCetirizine HCl 1 mg /ml oral solution antihistamine

Cetirizine HCl 1 mg /ml oral solution antihistamine

Indoor & Outdoor Allergies

Bubble GumSyrup

Bubble GumSyrup

Dye-Free • Sugar-FreeDye-Free • Sugar-Free

Bubble GumSyrup

Dosing Cup IncludedDosing Cup Included

Dosing cup should be washed and left to air dry after each use.

The trade dress of this ZYRTEC® package is subject totrademark protection.

®

Indoor & Outdoor Allergies

ALLERGYCetirizine HCl 1 mg /ml oral solution antihistamine

Cetirizine HCl 1 mg /ml oral solution antihistamine

Dye-Free • Sugar-FreeDye-Free • Sugar-Free

Bubble GumSyrup

Bubble GumSyrup

Bubble GumSyrup

®

Relief of• Sneezing• Runny Nose• Itchy, Watery Eyes• Itchy Throat or Nose

24hour

Indoor & Outdoor Allergies

4 fl oz (118 ml)4 fl oz (118 ml) Dosing Cup Included

ALLERGYCetirizine HCl 1 mg /ml oral solution antihistamine

Cetirizine HCl 1 mg /ml oral solution antihistamine

yrs.& older2

Bubble GumSyrup

Bubble GumSyrup

Bubble GumSyrup

Dye-Free • Sugar-FreeDye-Free • Sugar-Free

Distributed by:McNeil Consumer HealthcareDivision of McNEIL-PPC, INC.Fort Washington, PA 19034 USA©McNEIL-PPC, INC. 2014 www.zyrtec.com00000000

Drug Facts Drug Facts (continued)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:� if breast-feeding: not recommended� if pregnant: ask a health professiona before use.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Cont ol Center right away. (1-800-222-1222)

Ask a doctor before use if you have liver or kidney disease. Your doctor should dete mine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product� drowsiness may occur� avoid alcoholic drinks� alcohol, sedatives, and tranquilizers may increase d owsiness� be careful when driving a motor vehicle or operating machinery

WarningsDo not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hyd oxyzine.

Active ingredient Purpose(in each 5 mL) Cetirizine HCl 5mg.....................................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

Other information � store between 20° to 25°C (68° to 77°F)� do not use if carton is opened or if carton tape or bottle wrap imprinted "SAFETY SEAL®" is broken or missing� see bottom panel for lot number and expiration date

Inactive ingredientsanhyd ous citric acid, flavors, propylene glycol, purified water, sodium benzoate, so bitol solution, sucralose

adults and children6 years and over

children 2 to under6 years of age

children under2 years of age

adults 65 yearsand over

ask a doctor

consumers withliver or kidneydisease

ask a doctor

5 mL or 10 mL once daily depending upon severity ofsymptoms; do not take more than 10 mL in 24 hours.

5 mL once daily; do not take more than 5 mL in 24 hours.

2 5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.

Directions � use only with enclosed dosing cup � find right dose on chart below� mL = milliliter

Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect).

3 0045-0205-049

LOT:

EXP:

USA000000

905

NDC 50580-721-05 NDC 50580-721-05

Reference ID: 3506951

(b) (4)

Page 4: Children's Zyrtec Allergy (Label) · Indoor & Outdoor Allergies Cetirizine HCl ALLERGY 1 mg /ml oral solution antihistamine 9nZ";gZZ Hj\Vg";gZZ Bubble Gum Syrup ® Relief of Sneezing

Dosing cup should be washed and left to air dry after each use.

ALLERGYCetirizine HCl 1 mg /ml oral solution antihistamine

Cetirizine HCl 1 mg /ml oral solution antihistamine

Relief of• Sneezing • Runny Nose• Itchy, Watery Eyes• Itchy Throat or Nose

4 fl oz (118 ml)

Indoor & OutdoorAllergies

Dye-Free • Sugar-FreeDye-Free • Sugar-Free

®

Active ingredient (in each 5 mL) Purpose C tirizine HCl mg…………………………............. AntihistamineUses temporar ly re ieves these symptoms due to hay fever or other upper respiratory allergies: � runny nose � sneezing � itchy, watery eyes � itching of the nose or throatWarnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product � drowsiness may occur � avoid alcoholic drinks � alcohol, sedatives, and tranquilizers may increase drowsiness � be careful when driving a motor vehicle or operating machineryStop use and ask a doctor if an a lergic reaction to this product occurs. Seek medical help right away.If pregnant or breast-feeding: � if breast-feeding: not recommended � if pregnant: 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. (1-800-222-1222)Directions � use only with enclosed dosing cup � mL = milliliter� 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. � adults 65 years and over: 5 mL once daily; do not take more than 5 mL in 24 hours. � children 2 to under 6 years of age: 2 5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2 5 mL every 12 hours. Do not give more than 5 mL in 24 hours.� children under 2 years of age: ask a doctor � consumers with liver or kidney disease: ask a doctor Other information � store between 20° to 25°C (68° to 77°F)� do not use if bottle wrap imprinted “SAFETY SEAL®” is broken or missingInactive ingredients anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate, sorbitol solu ion, sucralose Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect).

Distr buted by: McNe l Consumer HealthcareDivision of McNEIL-PPC, INC., Fort Washington, PA 19034 USA©McNEIL-PPC, INC. 20 4 www.zyrtec.com 00000000

NDC 50580-721-05

Reference ID: 3506951

(b) (4)

Page 5: Children's Zyrtec Allergy (Label) · Indoor & Outdoor Allergies Cetirizine HCl ALLERGY 1 mg /ml oral solution antihistamine 9nZ";gZZ Hj\Vg";gZZ Bubble Gum Syrup ® Relief of Sneezing

---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

THERESA M MICHELE05/16/2014

Reference ID: 3506951