ALLERGY RELIEF- cetirizine tablets tablet, film coated

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient (in each tablet)

Cetirizine hydrochloride USP, 10 mg

Purpose

Antihistamine

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

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 haveliver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you aretaking 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.

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

• store between 20° to 25°C (68° to 77°F).

Inactive ingredients

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

Questions or comments?

call toll-free 1-888-235-2466

SPL UNCLASSIFIED SECTION

TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

KEEP THE CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by the owners of Zyrtec® Tablets.

SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

MADE IN INDIA

Distributed by:
Discount Drug Mart
211 Commerce Drive, Medina, Ohio 44256
www.discount-drugmart.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORIGINAL PRESCRIPTION STRENGTH

Compare to Zyrtec ®active ingredient*

Allergy Relief

Cetirizine Hydrochloride Tablets USP, 10 mg

Antihistamine

Allergy

Indoor & Outdoor Allergies

6 Years and Older

 Sneezing        Itchy, Watery Eyes
Runny Nose    Itchy Throat or Nose

30 TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORIGINAL PRESCRIPTION STRENGTH

Compare to Zyrtec® active ingredient*

Allergy Relief

Cetirizine Hydrochloride Tablets USP, 10 mg

Antihistamine

Allergy

Indoor & Outdoor Allergies

6 Years and Older

24 Hour Relief of:

Sneezing Itchy, Watery Eyes
Runny Nose Itchy Throat or Nose

60 TABLETS

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
cetirizine tablets tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53943-130
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
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POVIDONE K30 (UNII: U725QWY32X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	CAPSULE (rounded off rectangular)	Size	9mm
Flavor		Imprint Code	S;521
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53943-130-13	1 in 1 CARTON	05/20/2026
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 53943-130-17	1 in 1 CARTON	05/20/2026
2		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078862	05/20/2026

Labeler - DISCOUNT DRUG MART, INC (047741335)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
OrBion Pharmaceuticals Private Limited		854403569	analysis(53943-130) , pack(53943-130) , label(53943-130) , manufacture(53943-130)