CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Strive Pharmaceuticals Inc

----------

Cetirizine HCl 10mg
All-Day Allergy Relief

Cetirizine HCl 10 mg

colloidal silicon dioxide, croscarmellose sodium, Hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

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 sedatives or tranquilizers.

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, ask a health professional before use.

Keep out of reach of children.

Keep out of reach of children.

OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Antihistamine

■ store at room temperature between 20-25°C (68-77°F).

■ close cap tightly after use.

■ contains no ingredient made from a gluten-containing grain (wheat, barley or rye).

TAMPER EVIDENT: Do not use if imprinted safety seal is broken or missing.

LabelCarton

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-139
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
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeRECTANGLESize9mm
FlavorImprint Code G;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70692-139-1414 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20927407/01/2020
Labeler - Strive Pharmaceuticals Inc (080028013)

Revised: 11/2020
Document Id: b451c631-6bdc-d42e-e053-2995a90af099
Set id: a4ebeec7-0245-4f77-e053-2995a90a7e7f
Version: 2
Effective Time: 20201117
 
Strive Pharmaceuticals Inc