FDA Label for 24hr Allergy Relief

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH TABLET)
PURPOSE
USES
WARNINGS
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
WHEN USING THIS PRODUCT
STOP USE AND ASK DOCTOR IF
IF PREGNANT OR BREAST-FEEDING:
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
CARTON LABEL
BOTTLE LABEL

24hr Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Leader/ Cardinal Health 110, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)

Levocetirizine dihydrochloride USP, 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Warnings

Do Not Use

if you have kidney disease
if you have ever had an allergic reaction to this product 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 Doctor If

you have trouble urinating or emptying your bladder
an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast-Feeding:

if breast-feding: 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 65 years of age and older	ask a doctor
adults and children 12-64 years of age	take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age	take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 tablet (2.5 mg) in 24 hours
children under 6 years of age	do not use
consumers with kidney disease	do not use

Other Information

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 torn or missing

Inactive Ingredients

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

Questions Or Comments?

Call 1-888-375-3784

Carton Label

LEADER

NDC 70000-0362-2

Original Prescription Strength

24HR Allergy Relief
Levocetirizine Dihydrochloride
Tablets USP, 5 mg I Antihistamine

24 Hour Relief of

Sneezing, Runny Nose
Itchy Nose or Throat, and
Itchy, Watery Eyes

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active ingredient*

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35 TABLETS

carton - carton

Bottle Label