Active Ingredient (in each tablet)

Cetirizine HCl 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:

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

drowsines may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinary.

Stop use and ask a doctor if an allergic reaction tothis 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:

store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

Inactive ingredients

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

Questions?

Call 1-844-874-7464

Manufactured by:

Unique Pharmaceutical Labs.

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

M. L. G/1430 Jul. 2020

126406

HOW SUPPLIED

NDC: 71335-0300-1: 30 Tablets in a BOTTLE

NDC: 71335-0300-2: 14 Tablets in a BOTTLE

NDC: 71335-0300-3: 7 Tablets in a BOTTLE

NDC: 71335-0300-4: 10 Tablets in a BOTTLE

NDC: 71335-0300-5: 15 Tablets in a BOTTLE

NDC: 71335-0300-6: 90 Tablets in a BOTTLE

NDC: 71335-0300-7: 20 Tablets in a BOTTLE

NDC: 71335-0300-8: 60 Tablets in a BOTTLE

NDC: 71335-0300-9: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Cetirizine Hydrochloride 10 mg Tablet

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0300(NDC:16571-402)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White)	Score	no score
Shape	BULLET (Barrel Shaped)	Size	8mm
Flavor		Imprint Code	CTN;10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0300-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/16/2018
2	NDC:71335-0300-2	14 in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018
3	NDC:71335-0300-3	7 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
4	NDC:71335-0300-4	10 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2019
5	NDC:71335-0300-5	15 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
6	NDC:71335-0300-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/16/2018
7	NDC:71335-0300-7	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/07/2019
8	NDC:71335-0300-8	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/13/2021
9	NDC:71335-0300-9	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077829	10/01/2009

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0300) , RELABEL(71335-0300)

Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy