EQUATE ALLERGY RELIEF- cetirizine hydrochloride tablet, film coated

Equate Allergy Relief by

Drug Labeling and Warnings

Equate Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., Cipla Ltd., Cipla limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses

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

• runny nose
• sneezing
• itchy, watery eyes
• itchy throat or nose

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: 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 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

Other information

• do not use if printed foil under cap broken or missing
• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

Colloidal silicon dioxide, Hypromellose, lactose monohydrate, low-substituted hydroxyporpyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.

Questions or Comments?

1-888-287-1915

Principal Display Panel - Carton Label

NDC: 49035-312-56

equate™

Allergy Relief

Cetirizine Hydrochloride Tablets USP, 10 mg
Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of:

• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat or nose

24
HOUR
SYMPTOM

RELIEF

Original Prescription Strength

10 mg

14 TABLETS

Principal Display Panel - Carton Label

NDC: 49035-312-57

equate™

Allergy
Relief

Cetirizine Hydrochloride
Tablets USP, 10 mg/Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of:

• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat or nose

24
HOUR
SYMPTOM

RELIEF

Original
Prescription Strength

10 mg

45 TABLETS

Principal Display Panel - Bottle Label

equate™

NDC: 49035-312-57

Allergy Relief

Cetirizine Hydrochloride
Tablets USP, 10 mg

Antihistamine

Original
Prescription
Strength

45 Tablets

Principal Display Panel - Carton Label

NDC: 49035-312-05

equate™

Allergy
Relief

Cetirizine Hydrochloride
Tablets USP, 10 mg/Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of:

• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat or nose

24
HOUR
SYMPTOM

RELIEF

Original
Prescription Strength

10 mg

90 TABLETS

Principal Display Panel - Bottle Label

equate™

NDC: 49035-312-05

Allergy Relief

Cetirizine Hydrochloride
Tablets USP, 10 mg

Antihistamine

Original
Prescription
Strength

90 Tablets

Principal Display Panel - Carton Label

NDC: 49035-312-58

equate™

Allergy Relief

Cetirizine Hydrochloride
Tablets USP,
10 mg/Antihistamine

Indoor and
Outdoor Allergies

24 Hour Relief of:

• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat or nose

24
HOUR
SYMPTOM

RELIEF

Original Prescription Strength

10 mg

180 TABLETS

INGREDIENTS AND APPEARANCE

EQUATE ALLERGY RELIEF 
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-312
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
colloidal silicon dioxide (UNII: ETJ7Z6XBU4)
hypromellose 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
lactose monohydrate (UNII: EWQ57Q8I5X)
hydroxypropyl cellulose, low substituted (UNII: 2165RE0K14)
magnesium stearate (UNII: 70097M6I30)
cellulose, microcrystalline (UNII: OP1R32D61U)
polyethylene glycols (UNII: 3WJQ0SDW1A)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	8mm
Flavor		Imprint Code	C;121
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-312-56	1 in 1 CARTON
1		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 49035-312-57	1 in 1 CARTON
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 49035-312-05	1 in 1 CARTON
3		90 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 49035-312-58	2 in 1 CARTON
4		90 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077318	07/25/2013

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Cipla Ltd. (650072015)

Establishment
Name	Address	ID/FEI	Business Operations
Cipla limited		650072015	MANUFACTURE(49035-312)

Establishment
Name	Address	ID/FEI	Business Operations
Cipla limited		916940208	API MANUFACTURE(49035-312)