ZERO ALLERGY- cetirizine hydrochloride tablet

Zero Allergy by

Drug Labeling and Warnings

Zero Allergy by is a Otc medication manufactured, distributed, or labeled by Efficient Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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).

ACTIVE INGREDIENT

Active Ingredient (per tablet)                 Purpose

Cetririzine HCl 10 mg ....................................Antihistamine

PURPOSE

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

Warnings

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

DO NOT USE

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.

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

KEEP OUT OF REACH OF CHILDREN

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)

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding:

• if breast-feeding: not recommended
• if pregnant: ask a health professional before use.
  

DOSAGE & ADMINISTRATION

Directions

• adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms
• adults 65 years and over: ask a doctor
• children 6 years of age: ask a doctor
• consumers with liver or kidney disease: ask a doctor

INDICATIONS & USAGE

Othe information

• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
• store between 20 degrees to 25 degrees C (68 to 77 degrees F)

INACTIVE INGREDIENT

Inactive ingredients

corn starch, hypromellose, lactose monhydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

QUESTIONS

Questions?

Call: 1-305-805-3456 M-F 9:00AM - 5:00PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZERO ALLERGY 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-827
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
POVIDONE (UNII: FZ989GH94E)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white	Score	no score
Shape	RECTANGLE	Size	9mm
Flavor		Imprint Code	RI52
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-827-14	14 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077498	04/01/2013

Labeler - Efficient Laboratories Inc (969044932)