Allergy Relief

Allergy Relief

Drug Labeling and Warnings

Drug Details

k">

CABINET ALLERGY RELIEF- cetirizine hydrochloride tablet, film coated 
Spirit Pharmaceutical LLC

----------

Allergy Relief

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 overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask 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®

image description

image description

CABINET ALLERGY RELIEF 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68210-0119
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
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
Colorwhite (white to off-white) Score2 pieces
ShapeRECTANGLE (rounded-off rectangular biconvex tablet) Size10mm
FlavorImprint Code G4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68210-0119-0100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2019
2NDC: 68210-0119-31 in 1 CARTON03/10/2020
230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20927410/25/2019
Labeler - Spirit Pharmaceutical LLC (179621011)
Registrant - Spirit Pharmaceutical LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236manufacture(68210-0119)

Revised: 3/2020
 
Spirit Pharmaceutical LLC


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.