Up And Up Childrens Allergy Relief (Cetirizine Hcl) Solution [Target Corporation] -

UP AND UP CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [TARGET CORPORATION]
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Active ingredient (in each 5 mL)

Cetirizine HCl 5 mg
Purpose

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
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 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 machinery

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 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

adults and children 6 years and over	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 carton is opened, or if printed neckband is broken or missing
•: see bottom panel for lot number and expiration date

INGREDIENTS AND APPEARANCE

UP AND UP CHILDRENS ALLERGY RELIEF
cetirizine hcl solution

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11673-475-34	1 in 1 CARTON	10/15/2015
1		236 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:11673-475-26	1 in 1 CARTON	01/19/2018
2		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204226	10/15/2015

Labeler - Target Corporation (006961700)

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