OTC Medication Information: Allergy Relief

ALLERGY RELIEF- cetirizine hydrochloride tablet, film coated
Strategic Sourcing Services LLC

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)

Inactive ingredients colloidal silicon dioxide**, croscarmellose sodium**, hypromellose, lactose, magnesium stearate, maize starch**, microcrystalline cellulose**, polyethylene glycol, povidone**, titanium dioxide **containes one or more of these ingrdients

Questions or comments? 833-358-6431

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ALLERGY RELIEF
cetirizine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1241
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MAIZE INVERT SUGAR
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape BULLET (barrel shaped, biconvex) Size 8mm
Flavor Imprint Code CTN;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70677-1241-1 120 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077829 01/23/2024
Labeler — Strategic Sourcing Services LLC (116956644)

Revised: 02/2024 Strategic Sourcing Services LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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