CETIRIZINE HYDROCHLORIDE tablet

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Sportpharm LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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 DOCTOR

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you aretaking tranquilizers or sedatives.

When using this product

• 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

Stop use and ask a doctorif an allergic reaction tothis 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 at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

Inactive ingredients

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

Questions?

Call 1-844-874-7464

SPL UNCLASSIFIED SECTION

Distributed by:

Sportpharm LLC

379 Van Ness Ave 1401,

Torrance, CA 90501

Relabeled and Repackaged by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85766-149(NDC:16571-402)
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (White)	Score	no score
Shape	BULLET (Barrel Shaped)	Size	8mm
Flavor		Imprint Code	CTN;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85766-149-10	10 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2026
2	NDC: 85766-149-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2026
3	NDC: 85766-149-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2026
4	NDC: 85766-149-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2026
5	NDC: 85766-149-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2026
6	NDC: 85766-149-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077829	10/01/2009

Labeler - Sportpharm LLC (125298538)