Children’s Xyzal Allergy 24 Hour Liquid
`Grape Liquid 5 oz Bottle Label
`03.01.22
`XYZ_Kids_24hr_50z_Grape Lig_LBL_FDA_842468-01_DSN2.ai
`(PDF of art being shown is submitted at 100% actualsize)
`
`Purpose
`Active Ingredient(In each 5 mL)
`Levocetirizine dihydrochloride 2.5 my...........Antihistamine
`Uses temporarily relieves these symptoms due to hay
`
`‘or any of its ingredients or to an antihistamine containing
`cetirizine Ask a doctor before use If you have = ever
`had trouble urinating or emptying your bladder 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 machinery Stop use and ask
`4 doctor If = you have trouble urinating or emptying your
`bladder = an allergic reaction tothis product occurs. Seek
`medicalhelp right away. If pregnant or breast-feeding:
`m if breast-feeding: not recommended m if pregnant: ask
`ahealth 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). pe
`
`Grape Flavor
`
`5'fl-0z. (148 mL)
`
`purified water, saccharin sodium,
`
`Directions = use only with enclosed dosing cup adults 65 years
`‘of age and older m ask a doctor adults and children 12-64 years:
`‘of age m take 5 mL or 10 mL oncedaily in the evening depending
`upon severity of symptoms = do not take more than 10 mL in 24
`hours children 6-11 years of age m take 5 mL once daily in the
`evening # do not take more than 5 mLin 24 hours children 2-5
`‘years of age = take 2.5 mL once daily in the evening = do not
`take more than 2.5 mLin 24 hours children under 2 years of age
`= do not use consumers with Kidney disease = do not use
`Note: mL = milliliters Offer Information = each 5 mL contains:
`sodium 3 mg = store between 20° and 25°C (68° and 77°F)
`= safety sealed: do not use if carton
`was opened or if printed foil inner
`seal on bottle is tom or missing
`Inactive Ingredients flavor, glacial
`acetic acid, glycerin, maltitol solution,
`methylparaben, propylparaben,
`
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`Reference ID: 5011192
`Reference ID: 5011192
`
`

`

`Children’s Xyzal Allergy 24 Hour Liquid
`Grape Liquid 5 oz Carton
`03.01.22
`XYZ_Kids_24hr_5oz Grape Lig_CTN_FDA_842469-01_DSN2.ai
`(PDFof art being shownis submitted at 100% actualsize)
`
`XYZAL
`
`ALLERGY 24HR
`
`
`
`24 HOURRELIEF
`
`*RUNNY NOSE «SNEEZING
`
`
` Drug Facts (continued)
`Directions
`Drug Facts
`¢ CLINICALLY PROVENRELIEF
`
`
`FOR 24 HOURS
`Active ingredient
`Purpose
`
`
`Huse only with enclosed dosing cup
`(in each 5 mL)
`
`
`
`Levocetirizine dihydrochloride 2.5 mg....Antihistamine adults 65 years|yack 3 doctor
`
`
` of age and older
`
`Uses
`
`
`@ take 5 mL or 10 mL oncedaily
`CLINICALLY PROVEN RELIEF FROM
`;
`£
`temporarily relieves these symptoms dueto hayfever
`
`
`
`adults and
`in the evening depending upon
`INDOOR AND OUTDOORALLERGIES
`2
`/
`,
`or other respiratory allergies:
`
`
`
`
`children 12-64
`severity of symptoms.
`runny nose
`Witchy, watery eyes
`
`
`
`years of age
`do not take more than 10 mL
`
`| sneezing
`itching of the nose orthroat
`in 24 hours
`
`
`
`
`
`Warnings
`
`
`Do not use
`take 5 mL oncedaily in the
`
`
`
`
`children 6-11
`if you have kidney disease
`evening
`
`
`
`@ do not take more than 5 mL
`years of age
`if you have ever had an allergic reaction to this
`in 24 hours
`
`
`
`productor anyof its ingredients or to an
`
`
`antihistamine containing cetirizine
`m take 2.5 mL once daily in the
`
`
`
`children 2-5
`Ask a doctor before useif you have
`evening
`
`
`
`
`years of age
`m ever hadtrouble urinatingor emptying yourbladder
`@ do nottake more than 2.5 mL
`
`
`
`.
`Whenusing this product
`inet howe
`
`
`
`
`children under
`| drowsiness may occur
`@ do not use
`
`levocetrzinedihydrochlorideoralsolution
`2 years of age
`@ avoid alcoholic drinks
`
`
`
`consumers with
`alcohol, sedatives, and tranquilizers mayincrease
`25 mg/5 mL antihistamine
`@ do not use
`
`
`drowsiness
`
`kidneydisease
`
`
`@ be careful when driving a motor vehicle or operating
`Note: mL = milliliters
`
`
`
`
`machinery
`
`
`« Alcohol Free
`
`Other information
`Stop use and ask a doctorif
`
`
`m an allergic reaction tothis productoccurs.Seek
`« Dye Free
`mstore between20°and 25°C (68° and77°F)
`youhavetrouble urinating or emptying your bladder
`meach 5 mL contains: sodium 3 mg
`¢ Sugar Free
`
`
`
`
`
`
`
`medicalhelp right away. safety sealed: do notuse if carton was openedorif
`
`
`y
`
`
`
`
`printed foil inner seal on bottle is torn or missing
`
`
`If pregnantor breast-feeding:
`
`
`
`lif breast-feeding: not recommended
`“ITCHY, WATERY EYES
`Inactive ingredients
`
`
`lif pregnant ask a health professional before use
`flavor, glacial acetic acid, glycerin, maltitol solution,
`*ITCHY NOSE OR THROAT
`
`
`
`Keep outof reach of children.
`methylparaben,
`propylparaben,purified water,
`In case of overdose, get medical help or contact a
`Mp Oe
`
`
`
`
`Uiquid
`saccharin sodium, sodium acetate trihydrate
`
`
`
`Poison Control Centerright away (1-800-222-1222).
`
`
`
`>
`Questions or comments?
`
`call 1-866-844-2798
`
`Read directions and warnings
`oo
`before use. Keepthis carton.
`It has important information.
`842469-01
`
`€
`
`
`
`
`om
`
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`167°35305
`
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`
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`Reference ID: 5011192
`Reference ID: 5011192
`
`

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`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`SHERRY A STEWART
`07/13/2022 09:22:56 AM
`
`NUSHIN F TODD
`07/13/2022 09:32:05 AM
`
`Reference ID: 5011192
`
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