CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
TIME CAP LABORATORIES, INC.

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682R Timely 49483-682 Cetirizine hydrochloride tablets USP 5 mg

DRUG FACTS

Active ingredient (in each tablet)

Cetirizine HCl 5 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 over1 or 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over1 tablet once a day; do not take more than 1 tablet in 24 hours.
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 corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

Questions or comments?

Call 1-877-290-4008

682R-timely-cetirizine10mg-100ct-label

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-682
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
Colorwhite (White to off white) Scoreno score
ShapeRECTANGLE (Rounded-off rectangular shaped) Size7mm
FlavorImprint Code J;219
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-682-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07893305/30/2022
Labeler - TIME CAP LABORATORIES, INC. (037052099)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(49483-682)

Revised: 5/2022
Document Id: dfbdaf6a-c5e8-c5f9-e053-2995a90ae2c6
Set id: dfbddafb-9455-5805-e053-2a95a90ad0d9
Version: 1
Effective Time: 20220524
 
TIME CAP LABORATORIES, INC.