CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Drug Ocean LLC

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Cetirizine Hydrochloride Tablets USP 10 mg

Drug Facts

Active Ingredients

Active Ingredient (in each tablet)                                                                    Purpose
Cetirizine HCl USP 10 mg..............................................................................................Antihistimine

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

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

Keep out of reach of children.

In case of overdose, get medical help or contact 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 sever 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) [See USP Controlled Room Temperature]

Inactive Ingredients

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

Questions?

Call 1-866-333-9792

DRUG OCEAN NDC 70985-002-01

Original Prescription Strength

Cetirizine Hydrochloride

Tablets USP

10 mg

6 yrs& older

100 Tablets

100 tablets

DRUG OCEAN NDC 70985-002-02

Original Prescription Strength

Cetirizine Hydrochloride

Tablets USP

10 mg

6 yrs& older

500 Tablets

500 TabletsDRUG OCEAN NDC 70985-002-03

Original Prescription Strength

Cetirizine Hydrochloride

Tablets USP

10 mg

6 yrs& older

30 Tablets

30 Tablets

DRUG OCEAN NDC 70985-002-04

Original Prescription Strength

Cetirizine Hydrochloride

Tablets USP

10 mg

6 yrs& older

90 Tablets

90 TabletsDRUG OCEAN NDC 70985-002-05

Original Prescription Strength

Cetirizine Hydrochloride

Tablets USP

10 mg

6 yrs& older

300 Tablets

300 Tablets

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70985-002
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
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size8mm
FlavorImprint Code CTN;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70985-002-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2016
2NDC:70985-002-02500 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2016
3NDC:70985-002-0330 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2021
4NDC:70985-002-0490 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2021
5NDC:70985-002-05300 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782911/08/2016
Labeler - Drug Ocean LLC (080381835)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceutical Laboratories650434645manufacture(70985-002)

Revised: 12/2023
Document Id: 0d1c36f6-2a58-53fd-e063-6394a90a99c4
Set id: ef78fb17-6905-4961-ab85-7f312b6555d0
Version: 5
Effective Time: 20231222
 
Drug Ocean LLC