CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet
DIRECT RX

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.

Active Ingredients (in each tablet) Purpose
Cetirizine HCl 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

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.

drowsines may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinary.

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

if breast-feeding: not recommended
if pregnant: ask a health professional before use.

In case of overdose, get medical help or contact Poison Control Center right away.

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

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CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-429(NDC:16571-402)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
STARCH, CORN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
TITANIUM DIOXIDE
HYPROMELLOSES
LACTOSE
Product Characteristics
Color white Score no score
Shape BULLET Size 8mm
Flavor Imprint Code CTN;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61919-429-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077829 12/22/2016
Labeler — DIRECT RX (079254320)
Registrant — DIRECT RX (079254320)
Establishment
Name Address ID/FEI Operations
DIRECT RX 079254320 repack (61919-429)

Revised: 01/2020 DIRECT RX

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