CETIRIZINE HYDROCHLORIDE tablet

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Marlex Pharmaceuticals, Inc, Sun Pharmaceutical Industries Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl, USP 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 useif 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 haveliver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you aretaking 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 ifan 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

• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
• store between 20° to 25° C (68° to 77° F)

Inactive ingredients

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

SPL UNCLASSIFIED SECTION

Manufactured for/ Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 10/22 SP

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC: 10135-0762-30

Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE

30 TABLETS

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC: 10135-0762-90

Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE

90 TABLETS

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC: 10135-0762-01

Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE

100 TABLETS

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC: 10135-0762-03

Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE

300 TABLETS

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC: 10135-0762-05

Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE

500 TABLETS

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-762
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white	Score	no score
Shape	RECTANGLE (rounded-off)	Size	9mm
Flavor		Imprint Code	RI52
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-762-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2022
2	NDC: 10135-762-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2022
3	NDC: 10135-762-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2022
4	NDC: 10135-762-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2022
5	NDC: 10135-762-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077498	10/01/2022

Labeler - Marlex Pharmaceuticals, Inc (782540215)