CAREALL ALLERGY RELIEF- cetirizine hcl tablet

CAREALL Allergy Relief by

Drug Labeling and Warnings

CAREALL Allergy Relief by is a Otc medication manufactured, distributed, or labeled by New World Imports. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Cetirizine HCl 10mg

PURPOSE

Antihistamine

KEEP OUT OF REACH OF CHILDREN

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away

INDICATIONS & USAGE

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 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 sedatives or tranquilizers

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.

DOSAGE & ADMINISTRATION

Adult and children over 6 years old: One 10mg tablet once daily: no more than one 10mg tablet in 24 hours.  A 5mg product may be appropriate for less severe symptoms

Adults 65 years and over: ask a doctor

Children under 6 years of age: ask a doctor

Consumers with liver or kidney disease: ask a doctor

PREGNANCY

If pregnant of breast-feeding:

If breast-feeding: not recommended.

If pregnant: ask a health professional before use.

INACTIVE INGREDIENT

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

OTHER SAFETY INFORMATION

Store between 20-25 degrees celcius (68-77 degrees farhenheit).

Do not use if imprinted seal under bottle cap is broken or missing

You may report side effects 1-888-952-0050

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL ALLERGY RELIEF 
cetirizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-104
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (White to off white)	Score	2 pieces
Shape	RECTANGLE (pillow shaped)	Size	9mm
Flavor		Imprint Code	G;4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-104-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/07/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209274	12/07/2023

Labeler - New World Imports (075372276)

Registrant - New World Imports (075372276)