Cetirizine Hydrochloride by LIDL US LLC 1194A-LDL-2021-1101

Drug Details [pdf]

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, coated
LIDL US LLC

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1194A-LDL-2021-1101

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl 10 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 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

Other information

store between 20 to 25°C (68 to 77°F)
retain carton for complete product information and warnings

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient in Zyrtec® Allergy

NDC: 71141-194-14

ORIGINAL PRESCRIPTION STRENGTH

Cetirizine Hydrochloride Tablets, 10 mg

Actual Size

by LiDL®

ANTIHISTAMINE

24 HOUR RELIEF OF:

SNEEZING

RUNNY NOSE

ITCHY, WATERY EYES

ITCHY THROAT OR NOSE

30 TABLETS

24 HOUR

INDOOR & OUTDOOR ALLERGIES

ALLERGY

image description

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-194
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white (white to off white)	Score	2 pieces
Shape	RECTANGLE (rounded off rectangualr)	Size	9mm
Flavor		Imprint Code	G;4
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 71141-194-14	1 in 1 CARTON	03/30/2021	09/30/2024
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209274	03/30/2021	09/30/2024

Labeler - LIDL US LLC (079389709)

Revised: 10/2023

Document Id: 08f1de9b-c4d0-e10e-e063-6394a90a5d93

Set id: bcbbcb24-2a58-917a-e053-2a95a90af9a9

Version: 3

Effective Time: 20231030