Cetirizine Hydrochloride Tablets USP

cetirizine hydrochloride by

Drug Labeling and Warnings

cetirizine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Unichem Pharmaceuticals (USA), Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated 
Unichem Pharmaceuticals (USA), Inc.

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Cetirizine Hydrochloride Tablets USP

DRUG FACTS

ACTIVE INGREDIENT

(IN EACH TABLET)

For 5 mg

Cetirizine Hydrochloride USP, 5 mg

For 10 mg

Cetirizine Hydrochloride USP, 10 mg

PURPOSE

Antihistamine

INDICATIONS AND USAGE

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)

DOSAGE AND ADMINISTRATION

For 5 mg

adults and children 6 years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over
1 tablet once a day; do not take more than 1 tablet in 24 hours.
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

For 10 mg

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

STORAGE AND HANDLING

  • store between 20oto 25oC (68o to 77oF)

INACTIVE INGREDIENT

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

QUESTIONS

call 1-866-562-4616 from Monday to Friday between 8.00 Am to 8.00 PM, EST

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India.

Manufactured for:

Company Logo

Hasbrouck Heights, NJ 07604.

PRINCIPAL DISPLAY PANEL

5 mg-100s container label
10 mg-100s container label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 29300-133
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLE (Rounded-off) Size7mm
FlavorImprint Code U;133
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 29300-133-1330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
2NDC: 29300-133-4545 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
3NDC: 29300-133-7575 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
4NDC: 29300-133-1990 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
5NDC: 29300-133-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
6NDC: 29300-133-05500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
7NDC: 29300-133-9966500 in 1 DRUM; Type 0: Not a Combination Product06/01/201801/20/2020
8NDC: 29300-133-00200000 in 1 DRUM; Type 0: Not a Combination Product06/01/201801/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868006/26/200901/20/2020
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 29300-134
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
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLE (Rounded Off) Size9mm
FlavorImprint Code U;134
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 29300-134-1330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
2NDC: 29300-134-4545 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
3NDC: 29300-134-7575 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
4NDC: 29300-134-1990 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
5NDC: 29300-134-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
6NDC: 29300-134-05500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
7NDC: 29300-134-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
8NDC: 29300-134-505000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201801/20/2020
9NDC: 29300-134-9935700 in 1 DRUM; Type 0: Not a Combination Product06/01/201801/20/2020
10NDC: 29300-134-00100000 in 1 DRUM; Type 0: Not a Combination Product06/01/201801/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868006/26/200901/20/2020
Labeler - Unichem Pharmaceuticals (USA), Inc. (181620514)

Revised: 1/2020
Document Id: 0a54888d-c949-44f5-b559-cc8d35bc7da3
Set id: 3a7b2304-daef-4580-b7e7-4fbd8c8d888f
Version: 6
Effective Time: 20200120
 
Unichem Pharmaceuticals (USA), Inc.