EQUATE ALLERGY RELIEF- cetirizine hydrochloride tablet, film coated 
Wal-Mart Stores, Inc.

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Drug Facts

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:

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

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:

24
HOUR
SYMPTOM

RELIEF

Original Prescription Strength

10 mg

14 TABLETS

Principal Display Panel - Carton Label

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:

24
HOUR
SYMPTOM

RELIEF

Original
Prescription Strength

10 mg

45 TABLETS

Principal Display Panel - Carton Label

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 - Bottle Label

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:

24
HOUR
SYMPTOM

RELIEF

Original
Prescription Strength

10 mg

90 TABLETS

Principal Display Panel - Carton Label

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 - Bottle Label

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:

24
HOUR
SYMPTOM

RELIEF

Original Prescription Strength

10 mg

180 TABLETS

Principal Display Panel - Carton Label
EQUATE ALLERGY RELIEF 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-312
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
cetirizine hydrochloride (UNII: 64O047KTOA) (cetirizine - UNII:YO7261ME24) cetirizine hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code C;121
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-312-561 in 1 CARTON
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:49035-312-571 in 1 CARTON
245 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:49035-312-051 in 1 CARTON
390 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:49035-312-582 in 1 CARTON
490 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07731807/25/2013
Labeler - Wal-Mart Stores, Inc. (051957769)
Registrant - Cipla Ltd. (650072015)
Establishment
NameAddressID/FEIBusiness Operations
Cipla limited650072015MANUFACTURE(49035-312)
Establishment
NameAddressID/FEIBusiness Operations
Cipla limited916940208API MANUFACTURE(49035-312)

Revised: 8/2015
Document Id: a0391ab1-e9cf-47cb-982d-992bd6a7ddf8
Set id: d641a0ac-9d74-440a-94fd-699ab0fe513d
Version: 2
Effective Time: 20150803
 
Wal-Mart Stores, Inc.