CABINET ALLERGY RELIEF- cetirizine hydrochloride tablet, film coated

CABINET Allergy Relief by

Drug Labeling and Warnings

CABINET Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceutical LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• 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

• 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

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

Inactive ingredients

colloidal silicon dioxide*, croscarmellose sodium*, hypromellose, lactose, magnesium stearate, maize starch*, microcrystalline cellulose*, polyethylene glycol, povidone*, titanium dioxide

*containes one or more of these ingrdients

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient
in Zyrtec®*

Allergy Relief

Cetirizine HCl 10mg

100 Tablets

*This product is not manufactured or distributed
by McNeil Consumer Healthcare, owner of the
registered trademark Zyrtec®

INGREDIENTS AND APPEARANCE

CABINET ALLERGY RELIEF 
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0119
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (white to off-white)	Score	2 pieces
Shape	RECTANGLE (rounded-off rectangular biconvex tablet)	Size	10mm
Flavor		Imprint Code	G4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0119-0	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2019
2	NDC: 68210-0119-3	1 in 1 CARTON	03/10/2020
2		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 68210-0119-1	300 in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209274	10/25/2019

Labeler - Spirit Pharmaceutical LLC (179621011)

Registrant - Spirit Pharmaceutical LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(68210-0119)