Cetirizine

Brand names: Allergy Relief, CETIRIZINE HYDROCHLORIDE, CareOne All Day Allergy, Cetirizine Hydrochloride, Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride, Medline, allergy and congestion relief d, cetirizine hydrochloride, up and up allergy plus congestion relief d, Cetirizine HCl, Cetirizine Hydrochloride Hives Relief, ZERVIATE

Warnings

Contraindication: Do not use if you have had allergic reactions to this product, its ingredients, or antihistamines containing hydroxyzine. Pre-use considerations: Consult a doctor before use if you have liver or kidney disease, or are taking tranquilizers/sedatives. During use: May cause drowsiness; avoid alcohol and be cautious when driving or operating machinery, as alcohol and sedatives may increase drowsiness. Pregnancy/Breastfeeding: Not recommended if breastfeeding; pregnant individuals should consult a health professional. Overdose: Contact Poison Control (1-800-222-1222) immediately.

Contraindications

CONTRAINDICATIONS Cetirizine hydrochloride is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine.

Overdose

OVERDOSAGE Overdosage has been reported with cetirizine hydrochloride. In one adult patient who took 150 mg of cetirizine hydrochloride, the patient was somnolent but did not display any other clinical signs or abnormal blood chemistry or hematology results. In an 18 month old pediatric patient who took an overdose of cetirizine hydrochloride (approximately 180 mg), restlessness and irritability were observed initially; this was followed by drowsiness. Should overdose occur, treatment should be symptomatic or supportive, taking into account any concomitantly ingested medications. There is no known specific antidote to cetirizine hydrochloride. Cetirizine hydrochloride is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested. The acute minimal lethal oral doses were 237 mg/kg in mice (approximately 95 times the maximum recommended daily oral dose in adults on a mg/m 2 basis, or approximately 40 times the maximum recommended daily oral dose in infants on a mg/m 2 basis) and 562 mg/kg in rats (approximately 460 times the maximum recommended daily oral dose in adults on a mg/m 2 basis, or approximately 190 times the maximum recommended daily oral dose in infants on a mg/m 2 basis). In rodents, the target of acute toxicity was the central nervous system, and the target of multiple-dose toxicity was the liver.

Uses

"Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies" including runny nose, sneezing, itchy/watery eyes, and itching of the nose or throat.

Dosage forms & strengths

Tablet Tablet, Chewable Tablet, Extended Release Tablet, Film Coated Tablet, Film Coated, Extended Release TABLET POWDER KIT SOLUTION TABLET, FILM COATED FOR SOLUTION

CETIRIZINE HYDROCHLORIDE 10 mg CETIRIZINE HYDROCHLORIDE 5 mg PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg Cetirizine Hydrochloride 10 mg Cetirizine Hydrochloride 5 mg CETIRIZINE HYDROCHLORIDE 10 mg/1 CETIRIZINE 1 g/g CETIRIZINE HYDROCHLORIDE 5 mg/5mL CETIRIZINE HYDROCHLORIDE 5 mg/1 CETIRIZINE 2.4 mg/mL

Directions use only with enclosed dosing cup find right dose on chart below mL = milliliter adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 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) TAMPER EVIDENT: DO NOT USE IF NECKBAND IMPRINTED “SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSSING.

Ingredients

Active:

ACTIVE INGREDIENT (in each 5 mL teaspoonful) Cetirizine HCl 5 mg

Inactive:

INACTIVE INGREDIENTS Sucrose, Glycerin, Propylene Glycol, Methylparaben, Propylparaben, Sodium Acetate, Glacial Acetic Acid, Artificial Grape Flavor, Purified Water. Questions? Call 1-877-835-5472 Monday through Friday 9AM – 5PM EST. *This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Zyrtec ® . Zyrtec ® is a registered trademark of UCB Pharma, S.A. Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 03-2015-01